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NCT Number: NCT02732639

A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

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.

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Key information

Conditions

Hepatitis D, Chronic Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis D Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bucharest, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

pegylated interferon (Peg-IFN) alfa-2a

Drug

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

Other names: PEGASYS

Primary outcomes

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

    Time frame: At Week 72

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

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

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants With Normal ALT at Week 48

    Time frame: At Week 48

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

  2. Percentage of Participants With Negative HDV RNA at Week 48

    Time frame: At Week 48

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

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

    Time frame: At Weeks 48 and 72

    Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.

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

    Time frame: At Screening and at Weeks 48 and 72

    Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.

  5. Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72

    Time frame: At Weeks 48 and 72

    Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.

  6. Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72

    Time frame: At Weeks 48 and 72

    Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 8, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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