A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB) - Not applicable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39436

Enrollment

Registered

2011-03-10

Start date

2011-06-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B infection of the liver

Interventions

Tenofovir disoproxil fumarate (TDF) 300 mg PO once daily in combination with Peginterferon a-2a (PEG), 180 µg subcutaneous injection once weekly Peginterferon a-2a (PEG), 180 *g, will be administere

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.;Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible.;HBV DNA for HBeAg- >= 2000 IU/ml, and HBeAg+ subjects >= 20000 IU/ml.;ALT > 54 U/L and 36 U/L and

Exclusion criteria

Exclusion criteria: Known bridging fibrosis or cirrhosis and/or decompensated liver disease;Decompensated liver disease;Absolute neutrophil count

Design outcomes

Secondary

Measure	Time frame
Secondary: • The proportion of subjects with HBsAg loss at Week 72 following treatment with TDF (48 weeks) plus PEG (16 weeks) combination versus PEG alone for 48 weeks or TDF alone • The proportion of subjects who experience HBsAg loss at Week 96 and Week 120 • The proportion of subjects with virological response (HBV DNA level	—

Primary

Measure	Time frame
The primary endpoint is: • The proportion of subjects with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF alone	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)