Trial | NCT00336518  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
Study Started
Jun 30
2006
Study Completion
Jul 31
2009
Last Update
Jun 13
2006
Estimate

Drug peginterferon alfa-2a

Drug ribavirin

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
No Results Posted