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NCT Number: NCT02731131

A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

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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 2

Primary location

Cagliari, 09042, Italy

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 the prior 6 months
  • Positive anti-delta for the prior 3 months
  • Positive HDV RNA at Screening
  • Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
  • Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
  • Negative pregnancy and adequate contraceptive use

Exclusion criteria

  • Antiviral therapy for CHD within previous 3 months
  • Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
  • Increased risk of metabolic liver disease
  • Decompensated liver disease
  • Elevated bilirubin
  • Poor hematologic or renal function
  • Drug/alcohol abuse within 1 year prior to study
  • History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
  • Organ transplantation with existing functional graft
  • Retinopathy or other ophthalmologic complication of diabetes or hypertension
  • Inclusion in another investigational trial within previous 12 weeks

Treatment and study plan

Peginterferon alfa-2a

Drug

Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.

Other names: Pegasys

Ribavirin

Drug

Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.

Other names: Copegus

Primary outcomes

  1. Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment

    Time frame: Week 96

    Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.

Secondary outcomes

  1. Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment

    Time frame: Week 48

    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.

  2. Number of Participants With ALT Normalization at 48 Weeks After End of Treatment

    Time frame: Week 96

    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.

  3. Number of Participants With ALT Normalization at End of Treatment

    Time frame: Week 48

    Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.

  4. Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment

    Time frame: Week 96

    Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.

  5. Number of Participants With Negative HDV RNA at End of Treatment

    Time frame: Week 48

    Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2016
Registry last updated
Jul 15, 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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