January 11, 2014

This study is not yet open for participant recruitment.

Verified January 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT02032888
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

Purpose

To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV/ HIV Coinfection

Condition Intervention Phase
Hepatitis C
Drug: Daclatasvir
Drug: 
Sofosbuvir

Phase 3

Study Type: Interventional

Study Design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Proportion of treatment-naive subjects with sustained virologic response 12 (SVR12) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-naive HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 12-week regimen

Secondary Outcome Measures:

  • Proportion of treatment-naive subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-naive HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 8 -week regimen

  • Proportion of treatment-experienced HCV subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-experienced HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 12-week regimen

  • Proportion of HIV/HCV coinfected subjects, in each treatment arm, with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as HCV RNA < LLOQ TD or TND at follow-up Week 12 without regard to infecting HCV genotype

  • Safety measured by deaths and the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities [ Time Frame: Up to EOT (Approximately 8/12 weeks depending on treatment regimen) + 7 days ] [ Designated as safety issue: Yes ]

    EOT = End of treatment

  • The proportion of subjects coinfected with HIV, in each treatment arm, who achieve HCV RNA < LLOQ-TD/TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12 (for subjects in the 12-week arm) and EOT; post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects coinfected with HIV, in each treatment arm, who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12 (for subjects in the 12-week arm) and EOT ] [ Designated as safety issue: No ]
  • The proportion of HIV/HCV coinfected subjects, in each treatment arm, with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1: Cohort 1a-Treatment-naive-12 weeks
Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 2: Cohort 1b-Treatment-naive-8 weeks
Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 8 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 3: Cohort 2-Treatment Experineced-12 weeks
Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir

Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with HCV genotype 1, 2, 3, 4, 5 or 6, as documented by positive HCV RNA at screening
  • HCV-Treatment-naive subjects
  • HCV treatment-experienced subjects are eligible. All permitted prior anti-HCV therapies must be discontinued or completed at least 12 weeks prior to screening
  • Subjects must have an HCV RNA ≥ 10,000 IU/mL at Screening
  • Subjects must have HIV-1 infection

Exclusion Criteria:

  • Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC)
  • Subjects infected with HIV-2
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria,a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032888

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director:
Bristol-Myers Squibb Bristol-Myers Squibb

More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888 History of Changes
Other Study ID Numbers: AI444-216
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

-------------------------------------------

This study is not yet open for participant recruitment.

Verified January 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT02032901
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

Purpose

To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV Genotype 3 infection

Condition Intervention Phase
Hepatitis C
Drug: Daclatasvir
Drug: 
Sofosbuvir

Phase 3

Study Type:
Interventional

Study Design:
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Proportion of treatment naive subjects with sustained virologic response 12 (SVR12) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

  • Proportion of treatment experienced subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Safety measured by frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities [ Time Frame: Up to end of treatment (EOT) (Week 12) + 7 days ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who achieve HCV RNA < LLOQ-TD/TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12; EOT; post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12; EOT ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve SVR12 by baseline cirrhosis (presence or absence) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with HCV genotype 3
  • Subjects who are HCV-Treatment-naive
  • Subjects who are HCV-treatment-experienced

    • Previous exposure to non-structural 5A (NS5A) inhibitors is prohibited
  • HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

  • HCV Genotypes other than genotype (GT) -3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032901

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032901 History of Changes
Other Study ID Numbers: AI444-218
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

-----------------------------------

This study is not yet open for participant recruitment.

Verified January 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT02032875
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

Purpose

This trial is open to patients with cirrhosis due to chronic HCV, and to patients who have already received a liver transplant for chronic HCV. All subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain conditions, the treatment duration may be extended for cirrhotic subjects. The study will test how well this combination of investigational drugs works to treat chronic HCV.

Condition Intervention Phase
Hepatitis C Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin
Phase 3

Study Type:
Interventional

Study Design:
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C Liver Transplantation

Drug Information available for: Ribavirin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Proportion of genotype (GT) -1 infected Cirrhotic subjects with sustained virologic response (SVR12) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) 12 weeks after end of treatment (EOT)

  • Proportion of GT-1 infected Post-transplant subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

    SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) 12 weeks after end of treatment (EOT)

Secondary Outcome Measures:

  • The proportion of subjects who achieve SVR12 rates in all Cirrhotic and Post-transplant subjects, respectively, regardless of infecting HCV genotype, and GT-2-6 independently [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
  • Safety measured by frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 clinical laboratory abnormalities [ Time Frame: Up to end of treatment (Week 12 of the treatment phase) + 7 days ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who achieve HCV RNA < LLOQ-TD/TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8, 12 and EOT; post-treatment Weeks 4, 8 and 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8, 12 and EOT ] [ Designated as safety issue: No ]
  • The proportion of subjects with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 in Cirrhotic and Post-transplant subjects respectively [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1a: Daclatasvir and Sofosbuvir in Cirrhotic subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 1b: Daclatasvir+Sofosbuvir+Ribavirin(Relapse Re-treatment)
Cirrhotic subjects who undergo transplant while on study treatment may enter an additional Treatment Extension or Relapse Re-treatment period
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks. Ribavirin tablet daily dose of 1000 - 1200 mg orally in two divided doses for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir Drug: Ribavirin
Experimental: Arm 1c: Daclatasvir and Sofosbuvir (Treatment Extension)
Cirrhotic subjects who undergo transplant while on study treatment may enter an additional Treatment Extension or Relapse Re-treatment period
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir
Experimental: Arm 2: Daclatasvir and Sofosbuvir in Post-transplant subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Sofosbuvir

Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with HCV Genotype 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of ≥ 10,000 IU/mL at screening
  • Subjects may be treatment-naïve or treatment-experienced
  • Cirrhotic subjects must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol
  • Post-transplant subjects must be at least 3 months post-transplant with no evidence of moderate or severe rejection

Exclusion Criteria:

  • History of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited
  • Current or known history of cancer (with the following exceptions: In situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within Milan criteria for transplantation) within 5 years prior to screening
  • Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures)
  • History of HIV infection or chronic hepatitis B virus (HBV) as documented by HBV serologies (e.g., HBsAg-seropositive). Subjects with resolved HBV infection may participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative)
  • Active hospitalization for decompensated liver disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032875

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director: Bristol-Myers Squibb  Bristol-Myers Squibb

More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032875 History of Changes
Other Study ID Numbers: AI444-215
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

-----------------------------------------