DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Continuing Treatment With Pegasys and Copegus

Information source: MŠjbetegekťrt AlapŪtvŠny
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: MŠjbetegekťrt AlapŪtvŠny

Official(s) and/or principal investigator(s):
János Schuller, Dr., Principal Investigator, Affiliation: Májbetegekért Alapítvány

Overall contact:
J√°nos 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

J√°nos Schuller, Dr., Phone: +36 1 455-8127

Szt. László Hospital, Budapest 1097, Hungary; Recruiting
J√°nos 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017