Trial record 96 of 436 for:    hepatitis b | Open Studies

An Open-Label, Multicenter, National Observational Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS (Peginterferon Alfa-2a 40kD) - The PRO B Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02201407
First received: July 22, 2014
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with PEGASYS in patients with chroni c hepatitis B (CHB). Patients who have never received any hepatitis B virus (HBV

) treatment and patients previously treated with nucleos(t)ide analogs are quali fied for enrollment. The observation period is 48 weeks (PEGASYS standard of car e treatment) and for up to 24 weeks thereafter (72 weeks in total).


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peginterferon Alfa-2a (PEGASYS) in theRapy of Patients With chrOnic Hepatitis B (CHB) - PRO B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with HBeAg-positive CHB acheiving sustained immune control, defined as a combined response: post-treatment HBeAg seroconversion, and HBV levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-negative CHB acheiving sustained immune control, defined as combined response: HBV DNA levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-positive CHB acheiving combined response: post-treatment HBeAg seroconversion, and HBV levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-negative CHB acheiving combined response: HBV DNA levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Incidence of laboratory test abnormalities [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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:   Non-Probability Sample
Study Population

Adult patients receiving treatment for chronic hepatitis B with PEGASYS according to standard of care and in line with the current summary of product characteristics and local labeling who have no contraindication to PEGASYS therapy as per the local label. Target population are naïve subjects (who have never received any hepatitis B virus treatment) and previously treated subjects with nucleos(t)ide analogs (NAs).

Criteria

Inclusion Criteria:

  • Male and female patients >/= 18 years of age
  • Hepatitis B virus e Antigen (HBeAg) positive or HBeAg negative serologically proven chronic hepatitis B (CHB) with or without cirrhosis (histologically verified at some point in the past)
  • Baseline hepatitis B virus (HBV) DNA >2,000 IU/ml
  • Elevated serum alanine aminotransferase (ALT) > Upper Limit of Normal (ULN)
  • Signed written informed consent
  • Patients treated with previous nucleos(t)ide analogs (NAs) therapy are eligible for this study

Exclusion Criteria:

  • Patients who have contraindications for peginterferon alfa-2a (PEGASYS®) in accordance with the approved summary of product characteristics (e.g., severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
  • Patients with ALT > 10 x ULN or evidence of hepatocellular carcinoma
  • Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
  • Patients with decompensated liver disease
  • Pregnant or breast-feeding women
  • A history of liver transplantation or planned for liver transplantation
  • Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contraindicated according to telbivudine label)
  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: NCT02201407

Contacts
Contact: Reference Study ID Number: ML29062 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

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: NCT02201407     History of Changes
Other Study ID Numbers: ML29062
Study First Received: July 22, 2014
Last Updated: August 4, 2014
Health Authority: Serbia: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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 September 16, 2014