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A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01855997
First received: May 8, 2013
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This phase 4 study is designed for the collection of blood biomarker samples fro m patients who have completed chronic hepatitis B treatment with at least 25 wee ks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supp orted or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participa te in this study will be in accordance with the ongoing studies or with the gene ral medical practice of the physician. Data from whole blood DNA samples collect ed in the GV28555 study or available from previously collected Roche Clinical Re pository (RCR) samples will be used for combined analysis with data from other a pplicable studies. Procedures will include blood sample collection (not applicab le for patients who previously have consented and donated RCR DNA samples) and m edical record capture.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Phase 4, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBE-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2A 40KD (PEG-IFN) +/- Nucleos(t)Ide Analogue

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HBV DNA (quantitative PCR Test in iU/ml) [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]
  • Change in HBsAg/anti-HBs [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]
  • Change in HBeAg/anti-HBe [ Time Frame: from baseline to end of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory analysis of association of single nucleotide polymorphisms and treatment responses [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events related to study-specific procedures [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood samples


Estimated Enrollment: 1200
Study Start Date: August 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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 who received therapy with Pegasys +/- nucleos(t)ide analogue

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis B
  • Previously enrolled in a Roche study and treated for CHB for at least 24 weeks with Pegasys +/- nucleoside analogue (lamivudine or entecavir) or Pegasys +/- nucleotide analogue (adefovir) with >/= 24 weeks post-treatment follow-up; or
  • Treated in general practice for CHB with Pegasys according to standard of care and in line with the current Summary of Product Characteristics/local labeling who have non contra-indication to Pegasys therapy as per local label and have been treated with Pegasys for at least 24 weeks and have >/= 24 week post-treatment response available at the time of blood sample collection

Exclusion Criteria:

  • Hepatitis A, hepatitis C or HIV infection
  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: NCT01855997

Contacts
Contact: Reference Study ID Number: GV28855 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
Austria
Completed
Wien, Austria, 1090
Bulgaria
Recruiting
Sofia, Bulgaria, 1407
Recruiting
Varna, Bulgaria, 9010
China
Recruiting
Beijing, China, 100039
Recruiting
Beijing, China, 100054
Recruiting
Beijing, China, 100044
Terminated
Beijing, China, 100054
Recruiting
Beijing, China, 100011
Completed
Changsha, China, 410008
Completed
Chengdu, China, 610041
Completed
Chongqing, China, 400010
Recruiting
Fu Zhou, China, 350005
Recruiting
Guangzhou, China, 510515
Recruiting
Guangzhou, China, 510060
Recruiting
Guangzhou, China
Recruiting
Hangzhou, China
Recruiting
Harbin, China, 150001
Recruiting
Jinan, China, 250021
Completed
Nanjing, China, 210003
Recruiting
Nanning, China, 530021
Active, not recruiting
Shanghai, China, 201508
Recruiting
Shanghai, China, 200021
Recruiting
Shen Zhen, China, 518020
Recruiting
Shi Jiazhuang, China, 050051
Completed
Urumqi, China, 830001
Active, not recruiting
Wuhan, China, 430030
Completed
Xi'an, China, 710038
Recruiting
Yinchuan, China, 750004
Recruiting
Zhengzhou, China, 450003
France
Completed
Clichy, France, 92118
Completed
Creteil, France, 94010
Completed
Rennes, France, 35033
Completed
Saint Laurent Du Var, France, 06721
Germany
Recruiting
Berlin, Germany, 10117
Recruiting
Berlin, Germany, 10969
Recruiting
Berlin, Germany, 13353
Recruiting
Hamburg, Germany, 20099
Recruiting
Hannover, Germany, 30625
Greece
Recruiting
Athens, Greece, 115 27
Recruiting
Larissa, Greece, 41 110
Recruiting
Thessaloniki, Greece, 546 42
Italy
Active, not recruiting
Caserta, Campania, Italy, 81100
Active, not recruiting
Napoli, Campania, Italy, 80131
Completed
Bologna, Emilia-Romagna, Italy, 40138
Active, not recruiting
Parma, Emilia-Romagna, Italy, 43100
Completed
Milano, Lombardia, Italy, 20122
Active, not recruiting
Bari, Puglia, Italy, 70124
Active, not recruiting
Castellana Grotte, Puglia, Italy, 70013
Active, not recruiting
Cagliari, Sardegna, Italy, 09042
Active, not recruiting
Palermo, Sicilia, Italy, 90127
Completed
Pisa, Toscana, Italy, 56124
Completed
Padova, Veneto, Italy, 35128
Korea, Republic of
Completed
Busan, Korea, Republic of, 633-165
Completed
Chooncheon, Korea, Republic of, 200-060
Completed
Seoul, Korea, Republic of, 135-710
New Zealand
Recruiting
Auckland, New Zealand, 100
Poland
Recruiting
Bydgoszcz, Poland, 85-030
Recruiting
Chorzow, Poland, 41-500
Recruiting
Krakow, Poland, 31-202
Completed
Lancut, Poland, 37-100
Completed
Lodz, Poland, 91-347
Recruiting
Warszawa, Poland, 02-507
Completed
Warszawa, Poland, 01-201
Recruiting
Zielona Góra, Poland, 65-044
Portugal
Completed
Lisboa, Portugal, 1649-035
Completed
Porto, Portugal, 4202-451
Completed
Porto, Portugal, 4099-001
Romania
Recruiting
Bucharest, Romania, 030303
Recruiting
Bucharest, Romania, 021105
Recruiting
Craiova, Romania, 200515
Taiwan
Completed
Changhua, Taiwan, 500
Completed
Kaohsiung, Taiwan, 807
Completed
Kaohsiung, Taiwan, 00833
Completed
Keelung City, Taiwan, 204
Completed
Taichung, Taiwan, 404
Completed
Taipei, Taiwan
Completed
Taipei, Taiwan, 100
Completed
Taipei, Taiwan, 112
Completed
Taoyuan, Taiwan, 333
Thailand
Completed
Bangkok, Thailand, 10700
Completed
Chiang Mai, Thailand, 50200
Completed
Songkhla, Thailand, 90112
United Kingdom
Active, not recruiting
London, United Kingdom, E1 1BB
Completed
Manchester, United Kingdom, M13 9WL
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: NCT01855997     History of Changes
Other Study ID Numbers: GV28855
Study First Received: May 8, 2013
Last Updated: November 17, 2014
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
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 20, 2014