|
Main
|
|
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: |
NCT02556307 |
|
Date of registration:
|
21/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
March 2009 |
|
Target sample size:
|
270 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02556307 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Clinical Trials |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hoffmann-La Roche |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male and female patients >/= 18 years
- Positive test for HCV
- Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin
labels
Exclusion Criteria:
- Concomitant infection with HIV or hepatitis B
- Participation in a clinical trial within 30 days prior to study start
- Any contraindications specified in the Peginterferon alfa-2a and ribavirin product
labels
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)
|
|
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
[Time Frame: 6 months after the last study drug administration (up to 123.6 weeks)]
|
|
Secondary Outcome(s)
|
|
Leukocyte Values
[Time Frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)]
|
|
Percentage of Participants With Undetectable HCV RNA
[Time Frame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)]
|
|
HCV RNA Values
[Time Frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)]
|
|
Thrombocyte Values
[Time Frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)]
|
|
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
[Time Frame: Up to 99.6 Weeks]
|
|
Hemoglobin Values
[Time Frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|