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Completed

NCT Number: NCT01390844

Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
  • Liver biopsy with histology consistent with CHC and no other etiology.
  • Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
  • Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
  • Weight between 40 kg and 125 kg, inclusive
  • Of 'local' ancestral descent
  • Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Exclusion criteria

  • Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
  • Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
  • Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
  • Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
  • Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Diabetes and/or hypertension with clinically significant ocular examination findings.
  • Any condition the could interfere with participation in and completion of the trial.
  • Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
  • Pregnant or breast-feeding.

Treatment and study plan

Boceprevir (BOC)

Drug

200 mg capsules, 800 mg three times daily by mouth

Other names: SCH 503034, Victrelis

Placebo to boceprevir

Drug

200 mg placebo capsules, 800 mg three times daily by mouth

Peginterferon alfa-2b (PEG)

Drug

1.5 mcg/kg/week subcutaneously

Other names: PegIntron, SCH 054031, Redipen

ribavirin (RBV)

Drug

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

Other names: Rebetol, SCH 018908

Cross-Over Boceprevir Treatment

Drug

At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Other names: SCH 503034, Victrelis

Primary outcomes

  1. Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population

    Time frame: Follow-up Week 24

    SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

  2. Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population

    Time frame: Follow-up Week 24

    SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

Secondary outcomes

  1. Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population

    Time frame: Follow-up Week 24

    SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

  2. Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population

    Time frame: Follow-up Week 24

    SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

  3. Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8

    Time frame: Treatment Week 8

    Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)

  4. Percentage of Participants in India Achieving EVR at Treatment Week 8

    Time frame: Treatment Week 8

    Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)

  5. Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan

    Time frame: Up to 96 weeks

    Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).

  6. Percentage of Participants With an AE of Anemia in India

    Time frame: Up to 96 weeks

    Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).

  7. Percentage of Participants With an AE of Neutropenia in Korea and Taiwan

    Time frame: Up to 96 weeks

    Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.

  8. Percentage of Participants With an AE of Neutropenia in India

    Time frame: Up to 96 weeks

    Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2011
Registry last updated
Sep 11, 2018

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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