Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a | Experimental | Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | 180 uG in 0.5 mL solution administered once weekly for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up | 72 Weeks | |
| Alanine Transaminase (ALT) Normalization at the End of Follow-Up | 72 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up | 72 Weeks | |
| Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up | 72 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pleven | 5800 | Bulgaria | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HBV DNA Suppression <20000 Copies/mL at the End of Treatment | 48 Weeks |
| Alanine Transaminase (ALT) Normalization at the End of Treatment | 48 Weeks |
| Plovdiv |
| 4002 |
| Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1431 | Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Sofia | 1612 | Bulgaria |
| Stara Zagora | 6000 | Bulgaria |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
Not provided
Not provided
Not provided