Continuing Treatment With Pegasys and Copegus
Information source: Májbetegekért Alapítvány
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: peginterferon alfa-2a (Drug); ribavirin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Májbetegekért Alapítvány Official(s) and/or principal investigator(s): János Schuller, Dr., Principal Investigator, Affiliation: Májbetegekért AlapÃtvány
Overall contact: János Schuller, Dr., Phone: +36 1 455-8127
Summary
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Secondary outcome: Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
János Schuller, Dr., Phone: +36 1 455-8127
Szt. László Hospital, Budapest 1097, Hungary; Recruiting János Schuller, Dr., Phone: +36 1 455-8228 Edit Villert, Phone: +36 1 455-8228
Additional Information
Starting date: June 2006
Last updated: June 12, 2006
|