Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients (HEPCAT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01125189 |
|
Recruitment Status :
Completed
First Posted : May 18, 2010
Results First Posted : October 23, 2015
Last Update Posted : October 23, 2015
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus | Drug: Daclatasvir Drug: Placebo Drug: peg-interferon alfa-2a Drug: ribavirin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 558 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | August 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg) |
Drug: Daclatasvir
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response Drug: peg-interferon alfa-2a Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys Drug: ribavirin Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Other Name: Copegus |
| Experimental: Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg) |
Drug: Daclatasvir
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response Drug: peg-interferon alfa-2a Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys Drug: ribavirin Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Other Name: Copegus |
| Placebo Comparator: Placebo plus peg-interferon alfa-2a and ribavirin |
Drug: Placebo
Tablets, oral, 0 mg, once daily, 24 weeks Drug: peg-interferon alfa-2a Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys Drug: ribavirin Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Other Name: Copegus |
Primary Outcome Measures :
- Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: Weeks 4 and 12 ]eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
- Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) [ Time Frame: Follow-up Week 24 ]SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died [ Time Frame: From start of study treatment (day 1) up to follow-up Week 48 ]SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Secondary Outcome Measures :
- Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR) [ Time Frame: Week 4 ]RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
- Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ]cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
- Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12) [ Time Frame: Follow-up Week 12 ]SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
- Percentage of Resistant Variants Associated With Virologic Failure [ Time Frame: Follow-up Week 48 ]
Virologic failure was defined as:
- Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
- <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
- Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
- HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24
- HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
- Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
- HCV RNA viral load of ≥100,000 IU/mL
- No previous exposure to interferon, pegIFNα, or RBV
- Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
- Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
- Body mass index of 18 to 35 kg/m^2
Exclusion Criteria:
- Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
- Evidence of a medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125189
Locations
Show 64 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01125189 |
| Other Study ID Numbers: |
AI444-010 2010-018295-24 ( EudraCT Number ) |
| First Posted: | May 18, 2010 Key Record Dates |
| Results First Posted: | October 23, 2015 |
| Last Update Posted: | October 23, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Interferons |
Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |