An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

Hepatitis C, Chronic Clinical Trial

Official title:

Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798576
• Other study ID #: ML28498
• Status: Terminated
• Phase: N/A
• First received: February 22, 2013
• Last updated: September 14, 2016
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial Summary

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 282
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin

• No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label

• Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:

• Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)

• Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment

• No co-infection with hepatitis B or human immunodeficiency virus (HIV)

Exclusion Criteria:

• History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C

• History of neurological disease

• History of severe psychiatric disease

• Decompensated diabetes

• History of immunologically mediated disease

• History of severe cardiac disease

• History or evidence of severe chronic pulmonary disease

• Inadequate hematologic function

• Pregnant or breastfeeding women

• Male partners of pregnant women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pegylated Interferon alfa-2a
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
• Ribavirin
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse)		approximately 3 years	No
Secondary	Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse)		approximately 3 years	No
Secondary	Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse)		approximately 3 years	No
Secondary	Percentage of patients with non-response/relapse/virological breakthrough/virological rebound		approximately 3 years	No
Secondary	Duration of treatment		approximately 3 years	No
Secondary	Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds		approximately 3 years	No
Secondary	Safety: Incidence of adverse events		approximately 3 years	No