Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667432
First received: August 15, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This prospective, multicenter, observational study will evaluate on-treatment pr edictors of response in patients with HBeAg positive or HBeAg negative chronic h epatitis B receiving treatment with Pegasys (peginterferon alfa-2a) in accordanc e with local labelling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 wee ks thereafter.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Observational, Non-Interventional Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with suppression of HBV DNA < 2,000 IU/ml [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • In HBeAg positive patients: Percentage of patients who become HBeAg negative and anti-HBe positive [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBsAg clearance: Percentage of patients who become HBsAg negative [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg clearance with other on-treatment factors in HBeAg positive and HBeAg negative patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg clearance with pre-treatment factors in HBeAg positive and HBeAg negative patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of serum ALT normalization: serum ALT/ALT ratio [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: June 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis B on treatment with Pegasys

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HBeAg positive or HBeAg negative hepatitis B with or without cirrhosis
  • Elevated ALT >ULN (upper limit of normal) but </=10 x ULN according to local label

Exclusion Criteria:

  • Contra-indications to Pegasys as detailed in the label
  • Co-infection with hepatitis A, hepatitis C or HIV
  • Concomitant treatment with telbivudine
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667432

Locations
Bulgaria
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1612
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1407
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667432     History of Changes
Other Study ID Numbers: ML25626
Study First Received: August 15, 2012
Last Updated: November 24, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014