36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01683786
First received: January 31, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

Purpose:

To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with undetectable HCV RNA at wk 8.

Study Design:

a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering this study.


Condition Intervention Phase
Hepatitis C Infection
Drug: Pegintron + Riba
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Effectiveness of 36 vs 48 Wks PegIntron Plus Ribavirin Treatment for HCV Patients Without Rapid Virologic Response(RVR) But With Undetectable HCV RNA at wk 8

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The rate of sustained virologic response [ Time Frame: At 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    The comparison of the rates of sustained virologic response (SVR) defined as the proportion of patients with loss of serum HCV RNA at week 24 of post-treatment between patient groups (36 vs 48 weeks of treatment period)


Secondary Outcome Measures:
  • the factors associated with sustained virologic response(SVR) between groups [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
    the SVR assessment is defined as 24 weeks after the end of treatment, which mean 48 weeks after randomization for the shorten treatment arm and 60 weeks after randomization for the standard treatment arm

  • the rate of end-of-treatment response(EOT) [ Time Frame: At the end of treatment (36 or 48 weeks of treatment period) ] [ Designated as safety issue: No ]
    The comparison of the rates of end-of-treatment response (EOT) defined as the proportion of patients with loss of serum HCV RNA at the end of treatment between patient groups (36 vs 48 weeks of treatment period)

  • The relapse rate [ Time Frame: At 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    The comparison of the relapse rates defined as the proportion of patients without detectable serum HCV RNA at the end of treatment but with detectable HCV RNA at 24 weeks after end of treatment between patient groups (36 vs 48 weeks of treatment period)


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegintron + Riba for 36 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 24 weeks (36 weeks in total HCV treatment)
Drug: Pegintron + Riba
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day
Active Comparator: Pegintron + Riba for 48 wks in total
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 36 weeks (48 weeks in total HCV treatment)
Drug: Pegintron + Riba
Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day

Detailed Description:

Purpose:

To compare the effectiveness of 36 wks versus 48 wks pegintron plus ribavirin treatment for HCV patients without RVR, but with undetectable HCV RNA at wk 8.

Study Design:

This is a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR at wk 4 but achieve undetectable HCV RNA at wk 8 (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated IFN-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering this study.

Study Duration:

The estimated recruitment period is 12 months; the follow-up duration is 72 weeks (longest treatment period plus 6 month- f/u period); the total study duration (FPE->LPLV) is estimated to be 2.5 years

Statistical Analysis and Sample Size Justification:

A. The study is not primarily designed for hypothesis testing; thus the sample size calculation is not based on the primary objective, Approximately 60 subjects (30 in each arm) will be recruited into this study B. For descriptive statistics, the continuous variables will be expressed as mean ± standard deviation, and the categorical variables will be performed the number of cases and the corresponding percentages.

The primary analysis will focus on the efficacy response to the shortened HCV treatment course (36 wks) compared with standard course (48 wks). The between-group difference for efficacy endpoint will be assessed by the difference in the percentage of virologic responder after 24 wks of HCV treatment. For univariate analyses, comparisons of independent samples (shortened vs. standard course) will be assessed with Student's t test. The comparisons of categorical variables will be assessed using the chi-square test. Regarding the multivariate analysis, the proportion of patients achieving virologic responder will be compared among groups using a logistic regression analysis with terms of potential confounding factors. The OR estimates will be derived from the logistic regression model and the corresponding 95% CIs will be used to quantify the each effect of treatment course length and confounding factors.

All randomized patients who take at least one dose of HCV regimen will be included in safety assessment. Fisher's exact test will be used to compare between-group incidences of AEs. For patients with any clinical AEs, treatment related AEs, serious AEs, or discontinuations because of AEs, the data among groups will be provided as well. Statistical significance will be determined at the 0.05 level for all tests.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 20y/o or older
  2. Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before initiating PegIFN plus RBV treatment
  3. HCV Genotype 1
  4. Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (< 50 IU/ml) with PegIFN plus RBV treatment
  5. Have received PegIFN plus RBV treatment for 12weeks with good compliance (who have received >80% of expected PegIFN and RBV doses and completed at least 80% of the expected duration (80/80/80 adherence) and achieve EVR before entering this study

Exclusion Criteria:

  1. Subjects with decompensated liver disease or overt cirrhosis by ultrasound.
  2. With prior exposures to interferon (standard or pegylated) treatment before baseline.
  3. With human immunodeficiency virus
  4. With hepatitis B infection
  5. With neutrophil count < 1500 mm3,
  6. With platelet count < 90000 mm3,
  7. With hemoglobin level < 12g/dL for men or < 11 g/dL for women
  8. With serum creatinine level > 1.5 mg/dL
  9. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
  10. Female patients with pregnancy or lactation. Pregnancy in partners of male patients.
  11. Hypersensitive to study drugs cases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683786

Contacts
Contact: Tsung-Hui Hu, M.D. 886-7-7317123 ext 8301 Dr.hu@msa.hinet.net

Locations
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch Recruiting
Kaohsiung, Taiwan
Contact: Tsung-Hui Hu, M.D.    886-7-7317123 ext 8301    Dr.hu@msa.hinet.net   
Principal Investigator: Tsung-Hui Hu, M.D.         
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Contact: Hsien-Chung Yu, M.D.    886-7-3422121 ext 2074    hcyu@vghks.gov.tw   
Principal Investigator: Tsung-Hui Hu, M.D.         
Pingtung Christian Hospital Recruiting
Pingtung, Taiwan, 900
Contact: Lian-Feng Lin, M.D.    886-8-7368686 ext 2032    lin.lian.feng@gmail.com   
Principal Investigator: Lian-Feng Lin, M.D.         
Chi Mei Medical Center - Liouying Branch Recruiting
Tainan, Taiwan, 736
Contact: Jyh-Jou Chen, M.D.    886-6-6226999 ext 72008    jjchen@mail.chimei.org.tw   
Principal Investigator: Jyh-Jou Chen, M.D.         
Shin Kong Wu Ho-Su Memorial Hosipital Recruiting
Taipei, Taiwan, 111
Contact: Chao-Sheng Liao, M.D.    886-2-28332211 ext 2031    M000642@ms.skh.org.tw   
Principal Investigator: Chao-Sheng Liao, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tsung-Hui Hu, M.D. Chang Gung Medical Foundation, Kaohsiung Branch
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01683786     History of Changes
Other Study ID Numbers: MISP39068
Study First Received: January 31, 2012
Last Updated: September 11, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014