Clinical trial NCT01429792: A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Official title: A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
* Documented pre-treatment HCV RNA quantitative result
* Compensated liver disease (Child-Pugh Grade A)
* Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria:

* Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
* Co-infection with active hepatitis A and/or hepatitis B
* History or evidence of a medical condition associated with liver disease other than HCV
* Signs and symptoms of hepatocellular carcinoma
* History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
* Therapy with antineoplastic treatment \</= 6 months prior to study day
* Diabetes mellitus in subjects receiving an insulin therapy
* Evidence of severe retinopathy
* Pregnant or breast-feeding women, and male partners of women who are pregnant

Primary outcomes:
measure: Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
timeFrame: Week 12
measure: Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
timeFrame: Week 12
measure: Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
timeFrame: Week 4
measure: Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
timeFrame: Week 4
measure: Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With pEVR to Study Treatment at Week 12
timeFrame: Week 12
measure: Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
timeFrame: Week 12
measure: Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Hospital; Gastroenterology
city: Ashdod
country: Israel
facility: Clalit City Ashdod MC; Liver Clinic
city: Ashkelon
country: Israel
facility: Barzilai MC; Gastroenterology
city: Bat Yam
country: Israel
facility: Batyamon; Liver Unit
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; 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: Petach Tikva
country: Israel
facility: Hasharon Mc; Gastroenterology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Gastroenterology
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; Gastroenterology
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
city: Tel Aviv
country: Israel
facility: Clalit Zamenhoff
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: