An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667432
First received: August 15, 2012
Last updated: March 2, 2015
Last verified: March 2015
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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:
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: | 141 |
| Study Start Date: | June 2011 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
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
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, 1527 | |
| Sofia, Bulgaria, 1407 | |
| Sofia, Bulgaria, 1606 | |
| 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: | March 2, 2015 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency |
Additional relevant MeSH terms:
|
Hepatitis B Hepatitis B, Chronic DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Chronic Hepatitis, Viral, Human |
Liver Diseases Virus Diseases Peginterferon alfa-2a Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015