NCT02732639

Brief Summary

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2005

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

April 5, 2016

Results QC Date

July 15, 2016

Last Update Submit

July 15, 2016

Conditions

Hepatitis D, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72

    Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.

    At Week 72

  • Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72

    Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.

    At Week 72

Secondary Outcomes (6)

  • Percentage of Participants With Normal ALT at Week 48

    At Week 48

  • Percentage of Participants With Negative HDV RNA at Week 48

    At Week 48

  • Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72

    At Weeks 48 and 72

  • Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels

    At Screening and at Weeks 48 and 72

  • Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72

    At Weeks 48 and 72

  • +1 more secondary outcomes

Study Arms (1)

Pegylated Interferon (PEG-IFN) alfa-2a

EXPERIMENTAL

Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.

Drug: Pegylated Interferon (PEG-IFN) alfa-2a

Interventions

Pegylated Interferon (PEG-IFN) alfa-2aDRUG

Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.

Also known as: PEGASYS
Pegylated Interferon (PEG-IFN) alfa-2a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
  • Positive anti-delta for at least 3 months prior to screening
  • Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
  • A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

You may not qualify if:

  • Antiviral therapy for CHD within the previous 6 months
  • Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • Other medical condition associated with chronic liver disease
  • Women with ongoing pregnancy or who are breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Bucharest, 021105, Romania

Location

Unknown Facility

Bucharest, 022328, Romania

Location

Unknown Facility

Cluj-Napoca, 400162, Romania

Location

Unknown Facility

Constanța, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Iași, 700111, Romania

Location

Unknown Facility

Timișoara, 293406, Romania

Location

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis DHepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 8, 2016

Study Start

October 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 26, 2016

Results First Posted

August 26, 2016

Record last verified: 2016-07

Locations

RO(7)