Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667432
First received: August 15, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with Pegasys (peginterferon alfa-2a) in accordance 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 weeks 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 350
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667432

Contacts
Contact: Reference Study ID Number: ML25626 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Bulgaria
Recruiting
Pleven, Bulgaria, 5800
Recruiting
Plovdiv, Bulgaria, 4002
Recruiting
Sofia, Bulgaria, 1431
Recruiting
Sofia, Bulgaria, 1612
Active, not recruiting
Sofia, Bulgaria, 1527
Recruiting
Sofia, Bulgaria, 1606
Recruiting
Sofia, Bulgaria, 1407
Recruiting
Stara Zagora, Bulgaria, 6000
Recruiting
Varna, Bulgaria, 9002
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: May 23, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency

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

ClinicalTrials.gov processed this record on May 23, 2013