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

June 12, 2006
June 12, 2006
June 2006
Not Provided
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Same as current
No Changes Posted
Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
Same as current
Not Provided
Not Provided
 
Continuing Treatment With Pegasys and Copegus
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: peginterferon alfa-2a
  • Drug: ribavirin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2009
Not Provided

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
Both
18 Years to 65 Years
No
Contact: János Schuller, Dr. +36 1 455-8127
Contact: Edit Villert +36 1 455-8127
Hungary
 
NCT00336518
MBA 1/2005, ML 20142, EuDract: 2005-004531-22
Not Provided
Not Provided
Májbetegekért Alapítvány
Hoffmann-La Roche
Principal Investigator: János Schuller, Dr. Májbetegekért Alapítvány
Májbetegekért Alapítvány
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP