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| Sponsor: | University of Turin, Italy |
|---|---|
| Information provided by: | University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT00575627 |
Purpose
Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT) levels have been generally excluded from treatment, because the strong conviction that normal ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: Peg-Interferon alpha2a plus Ribavirin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Chronic Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels With Peginterferon α-2a (40 kDa) Plus Ribavirin |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 2 | |
|
Experimental: 1
Drug: peginterferon α-2a (40 kDa) plus ribavirin for 24-48 weeks
|
Drug: Peg-Interferon alpha2a plus Ribavirin
Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: RIZZETTO Mario, MD | +39-011-6336397 | m.rizzetto@molinette.piemonte.it |
| Contact: CIANCIO Alessia, MD, PhD | +39-011-6336224 | aciancio3@molinette.piemonte.it |
| Italy | |
| Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette, | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Ciancio Alessia, MD, PhD +39-0116336224 aciancio3@molinette.piemonte.it | |
| Principal Investigator: Ciancio Alessia, MD, PhD | |
| Principal Investigator: | Rizzetto Mario | Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette, |
More Information
| Responsible Party: | Prof Mario Rizzetto - Dipartimento di GastroEpatologia - Università degli Studi di Torino, Università degli Studi di Torino |
| ClinicalTrials.gov Identifier: | NCT00575627 History of Changes |
| Other Study ID Numbers: | pNNALTHCV, NNALT |
| Study First Received: | December 14, 2007 |
| Last Updated: | June 3, 2008 |
| Health Authority: | Italy: Ethics Committee |
|
Hepatitis C persistently normal ALT pNNALT |
Theraphy for Hepatitis C Pegylated Interferon Combined therapy |
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a |
Interferons Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites |