NCT01088659 is a Phase 3 clinical trial of peginterferon alfa-2a [Pegasys] in Hepatitis D, Chronic, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01088659?

NCT01088659 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01088659?

Interventions in NCT01088659: peginterferon alfa-2a [Pegasys], placebo, tenofovir.

What condition does NCT01088659 study?

NCT01088659 studies Hepatitis D, Chronic.

Is NCT01088659 still recruiting?

NCT01088659 is currently completed. Last updated 14 January 2019.

Last reviewed 2019-01-14 · How we verify

NCT01088659

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

Completed Phase 3 Last updated 14 January 2019

What this trial tests

Phase 3 trial testing peginterferon alfa-2a [Pegasys] in Hepatitis D, Chronic in 50 participants. Completed in 29 December 2017.

Timeline

16 February 2010

Primary endpoint
29 December 2017

29 December 2017

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	16 February 2010
Primary completion	29 December 2017
Estimated completion	29 December 2017
Sites	6 locations across Turkey (Türkiye)

Drugs / interventions tested

peginterferon alfa-2a [Pegasys]
placebo
tenofovir — full drug profile →

Conditions studied

Hepatitis D, Chronic — all drugs for Hepatitis D, Chronic →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Hepatitis D, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial.
Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, et al · · 2019 · cited 143× · PMID 30833068 · DOI 10.1016/s1473-3099(18)30663-7

Verify or expand the search:

Other trials of peginterferon alfa-2a [Pegasys]

Trials testing the same drug.

NCT01519960 — A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B · Phase 3 · completed
NCT00922207 — A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Posit · Phase 4 · completed
NCT01429792 — A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated W · Phase 4 · completed

Other recruiting trials for Hepatitis D, Chronic

Currently open trials in the same condition.

NCT06603311 — Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of · NA · active not recruiting
NCT04166266 — National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01088659 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 14 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01088659.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing