Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01706575
Other study ID # ML28262
Secondary ID 2012-000080-25
Status Completed
Phase Phase 2
First received October 10, 2012
Last updated March 1, 2016
Start date April 2013
Est. completion date October 2015

Study information

Verified date March 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Italy: Agenzia Italiana del Farmaco (AIFA)
Study type Interventional

Clinical Trial Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in patients with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, patients with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the patients will continue their NA treatment.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult patients, 18 - 65 years of age

- Chronic hepatitis B

- Negative for HBeAg

- On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months

- HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys

- Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from Week -12 to start of the Add-on phase)

- Negative pregnancy test for women of childbearing potential

- Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase

Exclusion Criteria:

- Coinfection with HAV, HCV, HDV, HIV

- Evidence of decompensated liver disease (Child-Pugh >/=6)

- History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)

- Known hypersensitivity to peginterferon alfa-2a

- Pregnant of breastfeeding women

- Evidence of alcohol and/or drug abuse

- History of severe psychiatric disease, especially depression

- History of immunologically mediated disease

- History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

- History or evidence of severe pulmonary disease associated with functional limitations

- History of severe cardiac disease

- History of severe seizure disorder or current anticonvulsant use

- Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry

- History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study

- History or other evidence of severe retinopathy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
nucleos(t)ide analogues
Adenovir, entecavir, lamivudine or tenofovir
peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly, 48 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with serum HBsAg decrease >/= 50% from baseline to the end of the combination treatment Pegasys plus NA (Study Week 48) approximately 2.5 years No
Secondary Proportion of patients with HBsAg decrease >/=1 log10 IU/ml from baseline to Week 48 approximately 2.5 years No
Secondary Change in HBsAg levels from baseline to Week 96 No
Secondary Proportion of patients with HBsAg </= 0.05 UI/ml at Week 48 approximately 2.5 years No
Secondary Proportion of patients with HBsAg </= 0.05 UI/ml at Week 72 approximately 2.5 years No
Secondary Proportion of patients with HBsAg </= 0.05 UI/ml at Week 96 approximately 2.5 years No
Secondary HBsAg levels according to IL28B genotypes approximately 2.5 years No
Secondary HBsAg levels according to IP-10 serum levels approximately 2.5 years No
Secondary Safety: Incidence of adverse events approximately 2.5 years No
See also
  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 NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B 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