A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033448
• Other study ID #: ML21778
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2009
• Last updated: May 5, 2017
• Start date: December 2009
• Est. completion date: June 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• COPEGUS
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
• peginterferon alfa-2a [Pegasys]
PEGASYS 180 micrograms sc once weekly for 24 weeks

Locations

Country	Name	City	State
Israel	Haemek Hospital; Gastroenterology	Afula
Israel	Clalit City Ashdod MC; Liver Clinic	Ashdod
Israel	Batyamon; Liver Unit	Bat Yam
Israel	Soroka Medical Center; Gastroenterology	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	Rabin Medical Center; Gastroenterology - Liver Unit	Petach Tikva
Israel	Kaplan Medical Center; Gastroenterology Unit	Rehovot
Israel	Clalit Pinsker Rishon; Liver Clinic	Rishon Lezion
Israel	Rebecca Sieff Medical Center; Liver Unit	Safed
Israel	Maccabi Health Services MC	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	End of Treatment Response Rate at Week 72 in Genotype 1	End of treatment response rate at Week 72 was reported for genotype 1.	Week 72
Primary	End of Treatment Response in Genotype 2 and 3	End of treatment response rate at Week 48 was reported for genotype 2 and 3.	Week 48
Primary	Sustained Viral Response (SVR) Rates in CHC Genotype 1	Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.	Week 96
Primary	SVR Rates in Genotype 2 and 3.	Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.	Week 72
Secondary	Percentage of Participants With Adverse Event (AE)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Week 96