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Trial record 50 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

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ClinicalTrials.gov Identifier: NCT02570191
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

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 : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B
Study Start Date : November 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peginterferon alfa-2a
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
Drug: Peginterferon alfa-2a
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Other Name: Pegasys




Primary Outcome Measures :
  1. Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up [ Time Frame: 72 Weeks ]
  2. Alanine Transaminase (ALT) Normalization at the End of Follow-Up [ Time Frame: 72 Weeks ]

Secondary Outcome Measures :
  1. Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up [ Time Frame: 72 Weeks ]
  2. Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up [ Time Frame: 72 Weeks ]
  3. HBV DNA Suppression <20000 Copies/mL at the End of Treatment [ Time Frame: 48 Weeks ]
  4. Alanine Transaminase (ALT) Normalization at the End of Treatment [ Time Frame: 48 Weeks ]


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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:

  • Adult participants 18-70 years of age
  • Positive test result for HBsAg for >6 months
  • Naive to treatment for HBV
  • On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

  • Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
  • Decompensated liver disease
  • Hepatocellular cancer
  • Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
  • Medical condition associated with chronic liver disease

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): NCT02570191


Locations
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Bulgaria
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1612
Stara Zagora, Bulgaria, 6000
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: NCT02570191     History of Changes
Other Study ID Numbers: ML18092
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 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