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BOLERO-CB: Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02060058
Collaborator
National Taiwan University Hospital (Other)
12
Enrollment
1
Location
3
Arms
34
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV
 Phase 3

Detailed Description

Liver disease, especially viral hepatitis, is an important public health issue, which frequent leads to liver cirrhosis, hepatocellular carcinoma (HCC) and liver-related death. Around 340 to 400 million persons are infected with hepatitis B virus (HBV) and 130 to 210 million persons are infected with hepatitis C virus (HCV) worldwide, In Taiwan, the prevalence of HBV infection is 15-20%, and the prevalence of HCV infection is 2-5% in general population. Moreover, there are some HCV-hyperendemic areas in southern Taiwan with anti-HCV prevalence rate of as high as 30-40%.

HBV/HCV dual infections is not uncommon in HBV epidemic areas, such as Southeastern Asia, with a prevalence rate of 1.1% in southern Taiwan. Recent study showed that the risk of HCC incidence is even higher among HBV/HCV co-infected persons than those with HBV or HCV mono-infection, indicating the importance of disease control in this clinical setting.

The PEG-IFN/RBV has been effective in the treatment of HCV-dominant, treatment-naïve patients with HCV/HBV dual infections. For treatment-naive HCV genotype 1 (HCV GT1)/HBV co-infected patients, 48 weeks of peginterferon (PEG-IFN) plus ribavirin (RBV) could achieve an HCV sustained virological response (SVR) rate of 72%, which was comparable to 77% for patients with HCV GT1 monoinfection. For treatment-naive HCV GT2 or GT3 /HBV co-infected patients, 24 weeks of PEG-IFN plus RBV could achieve an HCV SVR rate of 83%, which was comparable to 84% for patients with HCV GT2/3 monoinfection . Furthermore, PEG-IFN plus RBV combination therapy could enhance seroclearance of hepatitis B surface antigen (HBsAg) with an HBsAg loss rate of upto 11%. Nevertheless, there is about 30% of HCV GT1/HBV and 20% of HCV GT2 or 3/HBV co-infected patients refractory to current PEG-IFN/RBV combination therapy, which remains at high risk of HCC and liver-related death.

Boceprevir is an oral antiviral drug, which is NS3/4A protease inhibitor. Boceprevir has been approved for treating HCV GT1 infection by Food and Drug Administration (FDA) on 11 May 2011. For HCV GT1 mono-infected patients who refractory to previous PEG-IFN plus RBV combination therapy, becoprevir combined with PEG-IFN/RBV triple therapy can improve the treatment efficacy. The SVR rate of becoprevir-based triple therapy is about 3 times when compared to patients who received PEG-IFN with RBV dual therapy [14].The investigators , therefore, hypothesize that boceprevir plus PEG-IFN/RBV is effective in treating HCV GT1/HBV dually infected patients who are refractory to previous PEG-IFN/RBV combination therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Boceprevir-based Triple Therapy to Rescue HCV Genotype 1/HBV Dually Infected Patients Refractory to Peginterferon Plus Ribavirin Combination Therapy
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with 32 week therapy

For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. Dosage of drugs: Boceprevir 800mg tid po, PegIntron 1.5 mcg/kg im QW, and Ribavirin 800 to 1400 mg/day PO divided BID Regimen adjusted according to body weight. Stop trial intervention for patients with 32 week therapy: for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped (Stop trial intervention for boceprevir, PEG-IFN and RBV for arm A).

Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV
Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
Other Names:
  • Stop trial intervention for arm A
  • Stop trial intervention for arm B
  • Stop trial intervention for arm C

    		•
    Experimental: Patients with 48 weeks therapy

    For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. Dosage of drugs: as Patients with 32 week therapy Stop trial intervention for patients with 48 weeks therapy: for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped (Stop trial intervention for boceprevir, PEG-IFN and RBV for arm B).

    Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV
    Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
    Other Names:
  • Stop trial intervention for arm A
  • Stop trial intervention for arm B
  • Stop trial intervention for arm C

    		•
    Experimental: Null responder or cirrhotic patients

    For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Dosage of drugs: as Patients with 32 week therapy Stop trial intervention for for null responder or cirrhotic patients: for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped (Stop trial intervention for boceprevir, PEG-IFN and RBV for arm C).

    Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV
    Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
    Other Names:
  • Stop trial intervention for arm A
  • Stop trial intervention for arm B
  • Stop trial intervention for arm C

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Full Analysis Set Participants Who Received HCV Anti-viral Therapy With Sustained Virological Response (SVR) [week 24]

      The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)

    Secondary Outcome Measures

    1. Key Secondary Endpoint of This Clinical Trial-SVR in mITT [week 24]

      The total 7 patients had SVR by mITT in this clincial-trial, which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of Boceprevir

    Other Outcome Measures

    1. The Other Responses in the mITT Population/Safty- HBV Virologic Response [week 24]

      HBV virologic response, defined as serum HBV DNA levels to < 200 IU/mL at follow-up week 24 among patients with detectable HBV DNA at baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Patient must be 20 years or older
      1. Patient must have HCV GT1 infection combined with HBV infection.
      1. Patients must be serum HCV RNA detectable, anti-HCV positive, HBsAg positive and HBeAg negative.
      1. Patient has previously failed treatment with PEG-IFN-α 2a or 2b/RBV for minimum of 12 weeks of treatment.
      1. Patient must have compensated liver disease consistent with CHC and/or CHB, and no other etiology. Note: patients with cirrhosis should have a liver imaging study (e.g. ultrasound, CT scan or MRI) within the preceding 6 months showing no evidence of hepatocellular carcinoma.
      1. Patient meets all of the requirements and none of the contra-indications for treatment with PEG-IFN alpha-2b/RBV or boceprevir defined in the labels for the PEG-IFN/RBV to be used in combination with boceprevir.
      1. Patient is able and willing to provide signed informed consent (prepared by and administered by the physician) as required by local country requirements.
    Exclusion Criteria:
      1. Mixed genotypes including HCV genotype other than genotype 1.
      1. Patient has received boceprevir, narlaprevir, telaprevir, or any other HCV protease inhibitor treatment.
      1. Patient has evidence of decompensated liver disease including but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
      1. Patient meets any of the following exclusionary hematologic and biochemical criteria (documentation required) Hemoglobin <12 gm/dL for females and <13 gm/dL for males Neutrophils <1500/mm3 Platelets <100,000/mm3
      1. Patient has an organ transplant other than cornea or hair.
      1. Patient is co-infected with human immunodeficiency virus (HIV)
      1. Patient requires or is anticipated to require any of the following prohibited medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives
      1. Patient with clinical diagnosis or evidence of substance abuse involving alcohol, intravenous drugs, inhalational psychotropics, narcotics, cocaine prescription or over-the-counter drugs.
      1. Patient previously demonstrated clinically significant hypersensitivity or other contraindication to any component of the boceprevir formulation. This drug contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
      1. Serious illness, including malignancy, active coronary artery disease or cardiac dysfunction within 24 weeks prior to study entry, that in the opinion of the site investigator may preclude completion of the treatment regimen.
      1. Major hemoglobinopathy (e.g., thalassemia major), coagulopathy or any other cause of or tendency to hemolysis or bleeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. Kaohsiung Taiwan 80787

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • National Taiwan University Hospital

    Investigators

    • Study Chair: Ming-Lung Yu, Professsor, Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02060058
    Other Study ID Numbers:
    • KMUHIRB-2013-10-03 (I)
    First Posted:
    Feb 11, 2014
    Last Update Posted:
    Mar 13, 2018
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    hepatitis C virus
    hepatitis B virus
    boceprevir
    null responder
    partial responder
    relapser
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis

    Study Results

    Participant Flow

    Recruitment Details As protocol
    Pre-assignment Detail As protocol
    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
    Period Title: Overall Study
    STARTED 4 0 8
    COMPLETED 4 0 8
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients Total
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Total of all reporting groups
    Overall Participants 4 0 8 12
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.9
    (16.0)
    50.6
    (9.2)
    48.0
    (11.7)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    4
    Infinity
    4
    50%
    Male
    4
    100%
    4
    Infinity
    8
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Full Analysis Set Participants Who Received HCV Anti-viral Therapy With Sustained Virological Response (SVR)
    Description The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)
    Time Frame week 24

    Outcome Measure Data

    Analysis Population Description
    For survey the total 12 chronic hepatitis C patients by FAS in different arms in this clinical- trial. Outcome Measure Data Table: For survey the total 8 chronic hepatitis C patients had SVR by FAS in different arms in this clinical- trial.
    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48. Stop trial intervention for boceprevir, PEG-IFN and RBV: Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
    Measure Participants 4 0 8
    Number [participants]
    4
    100%
    4
    Infinity
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Patients With 32 Week Therapy, Patients With 48 Weeks Therapy, Null Responder or Cirrhotic Patients
    Comments
    Type of Statistical Test Other
    Comments The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Chi-squared
    Comments
    2. Secondary Outcome
    Title Key Secondary Endpoint of This Clinical Trial-SVR in mITT
    Description The total 7 patients had SVR by mITT in this clincial-trial, which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of Boceprevir
    Time Frame week 24

    Outcome Measure Data

    Analysis Population Description
    MITT population included subjects receiving ≥ 1 dose of boceprevir.
    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
    Measure Participants 4 0 7
    Number [participants]
    4
    100%
    3
    Infinity
    3. Other Pre-specified Outcome
    Title The Other Responses in the mITT Population/Safty- HBV Virologic Response
    Description HBV virologic response, defined as serum HBV DNA levels to < 200 IU/mL at follow-up week 24 among patients with detectable HBV DNA at baseline
    Time Frame week 24

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
    Measure Participants 4 0 8
    Number [participants]
    0
    0%
    0
    NaN

    Adverse Events

    Time Frame The specific period of time over which adverse event data were collected from baseline to end of follow up.
    Adverse Event Reporting Description Adverse events (AEs) data were collected on all patients during their treatment and posttreatment 6-month follow-up period. These data included clinical and laboratory grade 3 or 4 AEs, serious adverse events (SAEs), and special interest events, such as grade 2 or higher anemia events, infections, hepatic decompensation and other cytopenias.
    Arm/Group Title Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Arm/Group Description For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is undetectable during 8-24 weeks, boceprevir+PEG-IFN/RBV triple therapy will be administered from week 5 to week 32. For non-cirrhotic patients whose response of previous HCV therapy with PEG-IFN/RBV were relapse or partial response, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 (boceprevir+ PEG-IFN/RBV). If HCV RNA is detectable at week 8 and undetectable at week 24, boceprevir+ PEG-IFN/RBV triple therapy will be administered from week 5 to week 32, followed by additional 12 weeks of PEG-IFN/RBV therapy. For null responder or cirrhotic patients, PEG-IFN/RBV lead-in therapy is performed during 0-4 weeks, then add boceprevir from week 5 to 48.
    All Cause Mortality
    Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/0 (NaN) 0/8 (0%)
    Serious Adverse Events
    Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/0 (NaN) 1/8 (12.5%)
    Infections and infestations
    Fever 0/4 (0%) 0/0 (NaN) 0/8 (0%)
    Pregnancy, puerperium and perinatal conditions
    pregnancy 0/4 (0%) 0/0 (NaN) 1/8 (12.5%)
    Other (Not Including Serious) Adverse Events
    Patients With 32 Week Therapy Patients With 48 Weeks Therapy Null Responder or Cirrhotic Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/4 (100%) 0/0 (NaN) 8/8 (100%)
    Gastrointestinal disorders
    Gastroenterology 4/4 (100%) 0/0 (NaN) 8/8 (100%)
    Skin and subcutaneous tissue disorders
    Dermatology 3/4 (75%) 0/0 (NaN) 7/8 (87.5%)

    Limitations/Caveats

    The limitation of this study is the limited case number.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine
    Organization Kaohsiung Medical University Hospital
    Phone +886-7-3121101 ext 6770
    Email hsmonyan@gmail.com
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02060058
    Other Study ID Numbers:
    • KMUHIRB-2013-10-03 (I)
    First Posted:
    Feb 11, 2014
    Last Update Posted:
    Mar 13, 2018
    Last Verified:
    May 1, 2016