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

NCT01798576 | Terminated

• 1 other identifier: ML28498
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• 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

• Percentage of patients with non-response/relapse/virological breakthrough/virological rebound

  approximately 3 years

• Duration of treatment

  approximately 3 years

• Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds

  approximately 3 years

Study Arms (1)

Pegylated interferon alfa-2a

Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs)

Drug: Pegylated Interferon alfa-2a; Drug: Ribavirin

Interventions

Pegylated Interferon alfa-2a DRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Also known as: Peginterferon alfa 2A

Pegylated interferon alfa-2a

Ribavirin DRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Pegylated interferon alfa-2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Brasov, 500326, Romania

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: November 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

RO (1)