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)

Hepatitis C, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429792
• Other study ID #: ML21779
• Status: Completed
• Phase: Phase 4
• Start date: September 25, 2008
• Est. completion date: June 10, 2013

Study information

• Verified date: December 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: June 10, 2013
• Est. primary completion date: June 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
standard treatment, subcutaneously weekly
• ribavirin [Copegus]
standard treatment, orally daily

Locations

Country	Name	City	State
Israel	Haemek Hospital; Gastroenterology	Afula
Israel	Clalit City Ashdod MC; Liver Clinic	Ashdod
Israel	Barzilai MC; Gastroenterology	Ashkelon
Israel	Batyamon; Liver Unit	Bat Yam
Israel	Soroka Medical Center; Gastroenterology	Beer Sheva
Israel	Soroka Medical Center; Liver Unit	Beer Sheva
Israel	Bnei-Zion Medical Center; Gastroenterology	Haifa
Israel	Carmel Hospital; Liver Unit	Haifa
Israel	Rambam Medical Center; Gastroenterology - Liver Unit	Haifa
Israel	Wolfson Hospital; Gastroenterology Unit	Holon
Israel	Clalit Strauss MC	Jerusalem
Israel	Hadassah Hospital; Liver Unit	Jerusalem
Israel	Meir Medical Center; Gastroenterology	Kfar Saba
Israel	Naharyia / Western Galilee MC; Gastro Unit	Nahariya
Israel	Holy Family Medical Center; Gastroenterology	Nazareth
Israel	Hasharon Mc; Gastroenterology	Petach Tikva
Israel	Rabin Medical Center; Gastroenterology - Liver Unit	Petach Tikva
Israel	Chaim Sheba Medical Center; Gastroenterology	Ramat Gan
Israel	Kaplan Medical Center; Gastroenterology Unit	Rehovot
Israel	Clalit Pinsker Rishon; Liver Clinic	Rishon Lezion
Israel	Rebecca Sieff; Gastroenterology	Safed
Israel	Clalit Zamenhoff	Tel Aviv
Israel	Maccabi Health Services MC	Tel Aviv
Israel	Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit	Tel Aviv
Israel	Poria Hospital; Gastroenterology	Tiberias
Israel	Assaf Harofeh; Gastroenterology	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment	The rate of participants with pEVR to study treatment was defined as = 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.	Week 12
Primary	Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment	The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment	Week 12
Primary	Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24	The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment	Week 24
Primary	Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.	Week 4
Primary	Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment	The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.	Week 4
Primary	Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24	The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.	Week 24
Secondary	Percentage of Participants With pEVR to Study Treatment at Week 12	The rate of participants with pEVR to study treatment was defined as = 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.	Week 12
Secondary	Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment	The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.	Week 12
Secondary	Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24	The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.	Week 24