Hepatitis B, Chronic Clinical Trial
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)
Verified date | November 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Bulgaria: Bulgarian Drug Agency |
Study type | Observational |
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 peginterferon alfa-2a (PEGASYS®) in accordance with local labeling 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.
Status | Completed |
Enrollment | 141 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients = 18 years of age. - Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis. - Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but = 10 x ULN according to local label. Exclusion Criteria: - Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label. - Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV). - Concomitant treatment with telbivudine. - Pregnant or lactating women. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml). | At the end of the study (Week 36) | No |
Primary | Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml | approximately 3 years | No | |
Primary | In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive | approximately 3 years | No | |
Secondary | Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative. | At the end of treatment (Week 24) | No |
Secondary | HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative | approximately 3 years | No | |
Secondary | Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients | approximately 3 years | No | |
Secondary | Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients | approximately 3 years | Yes | |
Secondary | Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio | approximately 3 years | No | |
Secondary | Safety: Incidence of Adverse Events | approximately 3 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03272009 -
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
|
Phase 1 | |
Recruiting |
NCT01456312 -
HBsAg Related Response Guided Therapy
|
Phase 4 | |
Terminated |
NCT01886300 -
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
|
N/A | |
Completed |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
Phase 1 | |
Completed |
NCT00536263 -
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
|
Phase 3 | |
Terminated |
NCT00460850 -
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
|
Phase 4 | |
Completed |
NCT03681132 -
The Norwegian Nucleoside Analogue Stop Study
|
Phase 4 | |
Active, not recruiting |
NCT05473806 -
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
|
Phase 4 | |
Withdrawn |
NCT01179594 -
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
|
Phase 4 | |
Recruiting |
NCT05057065 -
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
|
||
Completed |
NCT04439539 -
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Withdrawn |
NCT03125213 -
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
|
Phase 2 | |
Active, not recruiting |
NCT04782375 -
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
|
Phase 4 | |
Withdrawn |
NCT05550519 -
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
|
Early Phase 1 | |
Completed |
NCT02693652 -
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT04160897 -
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
|
||
Active, not recruiting |
NCT02588937 -
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
|
Phase 4 | |
Completed |
NCT02612506 -
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT02327416 -
A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
|
Phase 3 |