Continuing Treatment With Pegasys and Copegus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Májbetegekért Alapítvány.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Májbetegekért Alapítvány
ClinicalTrials.gov Identifier:
NCT00336518
First received: June 12, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment

Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods


Condition Intervention Phase
Chronic Hepatitis C
Drug: peginterferon alfa-2a
Drug: ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24

Resource links provided by NLM:


Further study details as provided by Májbetegekért Alapítvány:

Primary Outcome Measures:
  • Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment

Secondary Outcome Measures:
  • Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: July 2009
Detailed Description:

Prospective, multicentre, randomized, open-label comparative study

According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response.

These patients can enter to the study at two time points:

  • at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased
  • at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.

Patients are randomized to one of the following arms:

  • S (standard) group: Pegasys&Copegus combined therapy 180 mcg/week & weight/based 1000-1200 mg/day for a total of 48 weeks of treatment
  • P (prolonged) group: Pegasys&Copegus combined therapy 180 mcg/week & -weight/based 1000-1200 mg/day for a total of 72 weeks of treatment.

After completing treatment period patients enter into a 24-week follow up.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline)

Subgroup 1:

  • Positive HCV PCR result at week 12 of the ongoing treatment
  • ALT > 1ULN, but the value decreased by week 12

Subgroup 2:

  • ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline
  • Positive HCV RNA PCR at week 24 of the ongoing treatment
  • GPT < 2 ULN at week 24 of the ongoing treatment.

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it
  • Any investigational drug usage at inclusion or within 6 weeks prior to it
  • Co/infection with hepatitis A, B or HIV
  • Any chronic liver disease other than HCV infection
  • Sign or symptom of hepatocellular carcinoma
  • Decompensated liver disease
  • History of depression or any other relevant psychiatric disease which, in the opinion of a psychiatrist or neurologist, contraindicates study therapy
  • Uncontrolled thyroid dysfunction
  • Severe retinopathy
  • Evidence of regular alcohol consumption at inclusion or within 1 year prior to it
  • Any side effect probably caused by ongoing combined treatment which, in the opinion of the investigator, contraindicates continuation of the therapy or necessitates dose reduction of any drug in the combination therapy
  • Unwillingness to provide informed consent

Subgroup 1:

Laboratory findings at week 16 of the ongoing combined Pegasys&Copegus treatment:

  • ANC <1000/mm3
  • PLT <75.000/mm3
  • hemoglobin <10g/dl
  • creatinine >1,5 ULN

Subgroup 2:

Laboratory findings at week 28 of the ongoing combined Pegasys&Copegus treatment:

  • ANC <1000/mm3
  • PLT <75.000/mm3
  • hemoglobin <10g/dl
  • creatinine >1,5 ULN
  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: NCT00336518

Contacts
Contact: János Schuller, Dr. +36 1 455-8127
Contact: Edit Villert +36 1 455-8127

Locations
Hungary
Szt. László Hospital Recruiting
Budapest, Hungary, 1097
Contact: János Schuller, Dr.    +36 1 455-8228      
Contact: Edit Villert    +36 1 455-8228      
Sponsors and Collaborators
Májbetegekért Alapítvány
Hoffmann-La Roche
Investigators
Principal Investigator: János Schuller, Dr. Májbetegekért Alapítvány
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00336518     History of Changes
Other Study ID Numbers: MBA 1/2005, ML 20142, EuDract: 2005-004531-22
Study First Received: June 12, 2006
Last Updated: June 12, 2006
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on July 22, 2014