Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755 AM2)
This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01544920
First received: February 28, 2012
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.
The regimens differ in the treatment for participants who achieve HCV ribonucleic acid (RNA) undetectability at the end of the peginterferon alfa-2a (PEG-IFN2a) plus ribavirin (RBV) 4 week lead-in. Participants receive either PEG-IFN2a plus RBV alone or BOC plus PEG-IFN2a plus RBV.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Biological: peginterferon alfa-2a Drug: ribavirin Drug: boceprevir |
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, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Overall Number of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 [ Time Frame: Baseline to Follow-up Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants Achieving SVR at Follow-up Week 24 Among Those Participants Who Had Achieved Rapid Virologic Response (RVR) [ Time Frame: Baseline to Follow-up Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1250 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PEG-IFN2a/RBV
Participants receive an initial 4 week lead-in of PEG-IFN2a/RBV. A 1:1 ratio randomization occurs at Week 4: Participants randomized to the active comparator arm will receive open label PEG-IFN2a/RBV for a total of 24 weeks if HCV RNA is undetectable at Week 4. Participants who are HCV RNA detectable at Week 4 (non-RVR) will follow a response guided therapy recommendation. These participants will receive BOC/PEG-IFN2a/RBV regimen at Week 6 to allow for the HCV RNA laboratory process turnaround. |
Biological: peginterferon alfa-2a
peginterferon alfa-2a vials 180 ug/week subcutaneous
Other Names:
Drug: ribavirin
ribavirin 1,000 mg/day (body weight <75 kg) or 1200 mg/day (body weight ≥75 kg) orally divided into two daily doses.
Other Names:
Drug: boceprevir
Four 200 mg capsules three times a day orally for a total daily dose of 2400 mg.
Other Names:
|
|
Experimental: BOC/PEG-IFN2a/RBV
Participants receive an initial 4-week lead-in of PEG-IFN2a/RBV. Participants randomized to the experimental arm at Week 4 will receive BOC/PEG-IFN2a/RBV for a total of 24 weeks if the HCV RNA is undetectable at Week 4 (RVR). Those participants who are HCV RNA detectable at Week 4 (Non-RVR) will follow a response guided therapy recommendation.
|
Biological: peginterferon alfa-2a
peginterferon alfa-2a vials 180 ug/week subcutaneous
Other Names:
Drug: ribavirin
ribavirin 1,000 mg/day (body weight <75 kg) or 1200 mg/day (body weight ≥75 kg) orally divided into two daily doses.
Other Names:
Drug: boceprevir
Four 200 mg capsules three times a day orally for a total daily dose of 2400 mg.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is ≥ 40 kg and ≤ 125 kg.
- Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL
- Has IL-28B CC allele gene
- Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).
Exclusion Criteria:
- Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive).
- Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.
- Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
- Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
- Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
- Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
- Is diabetic and/or hypertensive
- Has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
- Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
- Hemoglobin <12 g/dL for females and <13 g/dL for males
- Neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of African descent
- Platelets <150,000/mm^3
- Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544920
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Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Show 71 Study LocationsSponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01544920 History of Changes |
| Other Study ID Numbers: | P07755, 2011-001345-32, MK-3034-040 |
| Study First Received: | February 28, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Hepatitis, Chronic Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013