Clinical trial NCT01945294: Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Official title: A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).


Eligibility criteria: Inclusion Criteria:

* weigh ≥ 40 kg and ≤ 125 kg
* have CHC genotype 1 infection
* has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
* must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Exclusion Criteria:

* participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
* is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
* has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
* has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
* has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
* taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
* has pre-existing psychiatric condition(s)
* has a clinical diagnosis of substance abuse
* 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
* is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)

Primary outcomes:
measure: Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
timeFrame: Follow-up Week (FW) 12 (up to 40 weeks)
Secondary outcomes:
measure: Percentage of Participants With Undetectable HCV RNA Across Treatment
timeFrame: TW4, TW8, and TW12
measure: Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
timeFrame: TW4, TW8, and TW12
measure: Percentage of Participants With Relapse
timeFrame: From EOT to FW12 (up to 12 weeks)
measure: Percentage of Participants With Neutropenia
timeFrame: Up to 60 weeks
measure: Percentage of Participants With Anemia
timeFrame: Up to 60 weeks
measure: Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
timeFrame: From TW1 through TW48
measure: Percentage of Participants With Treatment-Related Serious AEs (SAEs)
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: