Roche trials database

Trial information

A Study of Combination Treatment with Pegasys (Peginterferon alfa) and Copegus (Ribavirin)in Patients with Chronic Hepatitis C

Status:

Completed

Protocol number:

ML16837

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Safety and tolerability of ribavirin (Ro 20-9963) in combination with peginterferon alfa in patients with chronic hepatitis C

Brief summary:

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up. Target sample size is 2695.

Study phase:

IV

Study type:

Interventional; Treatment; Non-randomized; Open label; Uncontrolled; Parallel; Safety study

Conditions:

• Hepatitis C, Chronic

Primary outcome:

1. safety and tolerability with regard to clinical AEs and laboratory parameters Time frame: assessed every 2 weeks throughout study and after 8 weeks follow-up

Key secondary outcomes:

1. safety with regard to hematological parameters Time frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up

Inclusion criteria:

• adult patients >/= 18 years of age
• serologic evidence of chronic hepatitis C infection
• compensated liver disease
• negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion criteria:

• history or other evidence of a medical condition associated with chronic liver disease other than HCV
• hepatitis A, hepatitis B or HIV infection
• hepatocellular carcinoma
• severe concomitant disease

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A N/A

Accepts healthy volunteers:

No

Anticipated start date:

October, 2002

Trial registration date:

02.06.2009

Date last updated:

04.06.2013

This trial was conducted at the following locations:

ISRAEL

• AFULA
• Ashkelon
• BAT YAM
• BEER SHEVA
• HADERA
• HAIFA
• HOLON
• JERUSALEM
• KFAR SABA
• NAHARIYA
• NAZARETH
• PETACH TIKVA
• Ramat Gan
• REHOVOT
• SAFED
• TEL AVIV
• ZERIFIN

Link to trial result