Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)

NCT ID: NCT00160251

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-07-31

Brief Summary

The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1A: PegIntron (PEG) + Ribavirin (RBV)

A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.

Group Type: ACTIVE_COMPARATOR

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400

A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: ACTIVE_COMPARATOR

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)

A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)

A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)

A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400

A single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)

A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800

By first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800

By second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

PegIntron (PEG)

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Interventions

Boceprevir (BOC)

100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID

Intervention Type: DRUG

PegIntron (PEG)

1.5 mcg/kg weekly subcutaneously

Intervention Type: BIOLOGICAL

Ribavirin (RBV)

200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])

Intervention Type: DRUG

Other Intervention Names

SCH 503034

Eligibility Criteria

Inclusion Criteria

• Documented infection with chronic hepatitis C (CHC), genotype 1.
• Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
• No evidence of cirrhosis on liver biopsy.
• Results of physical examination and laboratory tests within specified ranges.
• Abstinence from use of abused substances.

Exclusion Criteria

• Women who are pregnant or nursing a child.
• Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
• Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
• Patients who relapsed following response to previous treatment.
• Evidence of advanced liver disease, or liver disease from a cause other than CHC.
• Pre-existing psychiatric condition.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P03659

Identifier Type: -

Identifier Source: org_study_id