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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT02726022
Date of registration:	29/03/2016
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels
Scientific title:	A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels
Date of first enrolment:	February 2007
Target sample size:	114
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02726022
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Greece

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay

- HCV ribonucleic acid (RNA) positive

- CHC with normal transaminases

- Compensated liver disease

- Non-pregnant and willing to use two contraceptive methods (if fertile)

- At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

- Pregnant or lactating women

- Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)

- History of seizures or depression

- History of autoimmune disease, severe heart or lung disease, or renal failure with
reduced creatinine clearance

- Uncontrolled thyroid disease

- Severe retinopathy

- Leukopenia or thrombocytopenia

- Bleeding esophageal varices or other evidence of hepatic decompensation

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Primary Outcome(s)

Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT [Time Frame: Baseline, EOT (up to 48 weeks)]

Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT [Time Frame: Baseline, 24 weeks after EOT (up to 72 weeks)]

Change From Baseline in SF-36 MCS at 24 Weeks After EOT [Time Frame: Baseline, 24 weeks after EOT (up to 72 weeks)]

Change From Baseline in SF-36 PCS at 24 Weeks After EOT [Time Frame: Baseline, 24 weeks after EOT (up to 72 weeks)]

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) [Time Frame: Baseline, EOT (up to 48 weeks)]

Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT [Time Frame: Baseline, EOT (up to 48 weeks)]

Secondary Outcome(s)

Secondary ID(s)

ML20151

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	15/08/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02726022

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