Trials / Unknown
UnknownNCT03957629
Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis
An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.
Detailed description
Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc. Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure. Comparing the rates of HBsAg and HBeAg serological conversion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenofovir Disoproxil Fumarate | Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day. |
| DRUG | PEG-Interferon alfa 2a | Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week. |
Timeline
- Start date
- 2019-11-06
- Primary completion
- 2021-07-30
- Completion
- 2023-07-30
- First posted
- 2019-05-21
- Last updated
- 2020-01-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03957629. Inclusion in this directory is not an endorsement.