Clinical trial NCT01756079: A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Official title: A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.


Eligibility criteria: Inclusion criteria:

* Weight between 40 kg and 125 kg
* Documented CHC genotype 1 infection
* Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
* Documented diagnosis of cirrhosis
* No evidence of hepatocellular carcinoma (HCC) by ultrasound
* Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)

Exclusion criteria:

* Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
* Use of any investigational drugs within 30 days prior to study enrollment
* Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
* Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
* Clinically significant ocular examination findings
* Pre-existing significant psychiatric condition(s)
* Clinical diagnosis of active or recent substance abuse
* Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

Primary outcomes:
measure: Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
timeFrame: Week 72 (24 weeks after end of treatment)
measure: Percentage of Participants With One or More Adverse Events
timeFrame: Up to 48 weeks (Lead-in and Treatment Periods)
measure: Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
timeFrame: Up to 48 weeks (Lead-in and Treatment Periods)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: