Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
Study NCT ID:
NCT01088659
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is \<50.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: