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Completed

NCT Number: NCT00160251

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)

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

Boceprevir (BOC)

Drug

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

Other names: SCH 503034

PegIntron (PEG)

Biological

1.5 mcg/kg weekly subcutaneously

ribavirin (RBV)

Drug

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

Primary outcomes

  1. Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

    Time frame: Baseline up to Week 49

    Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.

    All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.

    For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.

    Arm 1A was not analyzed.

  2. Percent of Participants Who Achieved Sustained Virologic Response (SVR)

    Time frame: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

    SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.

    All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.

    For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.

    Arm 1A was not analyzed.

Secondary outcomes

  1. Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

    Time frame: Baseline up to Week 73 [24 weeks after EoT]

    Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.

  2. Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

    Time frame: Week 1 and Week 49

    For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:

    Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).

    Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.

  3. Percent of Participants With Virologic Response Prior to Amendment 2

    Time frame: Week 3, Week 5, Week 13

    Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.

  4. Peak Plasma Concentration of Boceprevir (BOC)

    Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

    All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

  5. Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

    Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

    All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

    The dosing interval of 8 hours is represented as the hr in the unit of measure.

  6. Trough Plasma Concentration Level

    Time frame: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

    All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.

  7. Change in Alanine Aminotransferase (ALT) Levels

    Time frame: Baseline up to dosing change (> 25 weeks)

    Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.

  8. Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

    Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

    Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).

  9. Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

    Time frame: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

    Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).

  10. Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

    Time frame: From dosing change to end of follow-up (Week 73) (up to 48 weeks)

    Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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