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Trial record 52 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

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ClinicalTrials.gov Identifier: NCT02791269
Recruitment Status : Completed
First Posted : June 6, 2016
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Peginterferon alfa-2a Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B
Study Start Date : January 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008


Arm Intervention/treatment
Experimental: HBeAg Negative Participants
HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Drug: Peginterferon alfa-2a
180 mcg SC injection QW for 48 weeks.
Other Name: Pegasys

Experimental: HBeAg Positive Participants
HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Drug: Peginterferon alfa-2a
180 mcg SC injection QW for 48 weeks.
Other Name: Pegasys




Primary Outcome Measures :
  1. Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) [ Time Frame: End of 24-weeks follow-up (Week 72) ]
    HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.

  2. Number of Participants With HBV-DNA <20,000 Copies/mL [ Time Frame: End of 24-weeks follow-up (Week 72) ]
    HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.


Secondary Outcome Measures :
  1. Number of Participants With HBV-DNA <400 Copies/mL [ Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up) ]
    HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.

  2. Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion [ Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up) ]
    HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.

  3. Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level [ Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up) ]
    ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).

  4. Number of Participants With HBeAg Seroconversion [ Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up) ]
    HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-cirrhotic participants
  • Hepatitis B surface antigen (HBsAg) positive for at least 6 months
  • Hepatitis B surface antibody (anti-HBs) negative
  • Elevated serum alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) but less than or equal to (</=) 10 times of ULN
  • HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants: HBV DNA >100,000 copies/mL by polymerase chain reaction (PCR)
  • Participants with chronic hepatitis B (CHB) who are treatment-naive
  • No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue
  • For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion

Exclusion Criteria:

  • Previous antiviral or IFN-based therapy for CHB before enrolment
  • Pregnant or breast feeding women participants
  • Evidence of decompensated liver disease
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
  • Previous or current hepatocellular carcinoma
  • History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Alpha-fetoprotein levels of >100 nanograms (ng)/mL
  • Severe psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study
  • Thyroid disease uncontrolled by prescribed medications
  • Evidence of severe retinopathy
  • Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791269


Locations
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New Zealand
Auckland, New Zealand
Hamilton, New Zealand
New Plymouth, New Zealand
Riccarton, Christchurch, New Zealand, 8011
Rotorua, New Zealand
Whangarei, New Zealand
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02791269     History of Changes
Other Study ID Numbers: ML19295
First Posted: June 6, 2016    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs