Clinical trial NCT01033448: A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
Official title: An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/= 18 years of age
* Chronic hepatitis C, genotype 1, 2, 3
* Compensated liver disease
* Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion Criteria:

* Decompensated liver disease
* Signs or symptoms of hepatocellular carcinoma
* Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

Primary outcomes:
measure: End of Treatment Response Rate at Week 72 in Genotype 1
timeFrame: Week 72
measure: End of Treatment Response in Genotype 2 and 3
timeFrame: Week 48
measure: Sustained Viral Response (SVR) Rates in CHC Genotype 1
timeFrame: Week 96
measure: SVR Rates in Genotype 2 and 3.
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants With Adverse Event (AE)
timeFrame: Week 96
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Hospital; Gastroenterology
city: Ashdod
country: Israel
facility: Clalit City Ashdod MC; Liver Clinic
city: Bat Yam
country: Israel
facility: Batyamon; Liver Unit
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Gastroenterology
city: Haifa
country: Israel
facility: Rambam Medical Center; Gastroenterology - Liver Unit
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center; Gastroenterology
city: Haifa
country: Israel
facility: Carmel Hospital; Liver Unit
city: Holon
country: Israel
facility: Wolfson Hospital; Gastroenterology Unit
city: Jerusalem
country: Israel
facility: Hadassah Hospital; Liver Unit
city: Jerusalem
country: Israel
facility: Clalit Strauss MC
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Gastroenterology
city: Nahariya
country: Israel
facility: Naharyia / Western Galilee MC; Gastro Unit
city: Nazareth
country: Israel
facility: Holy Family Medical Center; Gastroenterology
city: Petach Tikva
country: Israel
facility: Rabin Medical Center; Gastroenterology - Liver Unit
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Gastroenterology Unit
city: Rishon Lezion
country: Israel
facility: Clalit Pinsker Rishon; Liver Clinic
city: Safed
country: Israel
facility: Rebecca Sieff Medical Center; Liver Unit
city: Tel Aviv
country: Israel
facility: Maccabi Health Services MC
city: Tiberias
country: Israel
facility: Poria Hospital; Gastroenterology
city: Zerifin
country: Israel
facility: Assaf Harofeh; Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: