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An Open-label Study of Pegasys in Combination With Lamivudine in Children With HBeAg-positive Chronic Hepatitis B in the Immune-Tolerant Phase

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Lamivudine (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Reference Study ID Number: NV25361 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of Pegasys plus lamivudine compared with an untreated control group in children with chronic hepatitis B in the immune-tolerant phase. For patients receiving the combination, the approximate total study length is 6 years and two months.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients with HBsAg loss at 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80)

Secondary outcome:

Proportion of patients with HBeAg loss

Proportion of patients with seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs)

Proportion of patients with seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe)

Composite outcome measure: Proportion of patients with HBV DNA levels: < 10^5 IU/ml, <10^4 IU/ml, undetectable; change from baseline in HBV DNA levels (by PCR or hybridization)

Proportion of patients with HBeAg seroconversion and HBV DNA <10^5 copies/ml (<20,000 IU/ml) (composite outcome measure)

Proportion of patients with HBeAg seroconversion and HBV DNA <10^4 copies/ml (<2,000 IU/ml) (composite outcome measure)

Safety (composite outcome measure): incidence, nature, and severity of serious and non-serious adverse events (AEs);reasons for the discontinuation of any study medication;dose modifications;changes in vital signs / laboratory tests;effect on growth

Safety (composite outcome measure): incidence, nature, and severity of persisting AEs, new-onset SAEs/non-serious AEs of special interest;changes in thyroid function from screening/baseline;effect on growth

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients 3 - 17 years of age at baseline (or 12 - 17 years of age at

baseline in Russia)

- Positive for hepatitis B surface antigen (HBsAg) and hepatitis B envelope antigen

(HBeAg) for more than 6 months prior to baseline

- Detectable hepatitis B virus (HBV)-DNA (> 10,000 copies/ml [> 2,000 IU/ml]) (as

measured by polymerization chain reaction [PCR] or hybridization) on at least 2 occasions one month apart with at least one of the determinations obtained - Compensated liver disease (Child-Pugh Class A clinical classification)

- Either a liver biopsy performed within 2 years prior to baseline showing no or

minimal fibrosis (based on Liver Biopsy Scores described in the protocol) and normal ALT levels (less than or equal to upper limit of normal [ULN]) sustained within 6 months prior to baseline, OR, normal ALT levels ( - Signed informed consent from parent/legal guardian and willingness of parent/legal

guardian to abide by the requirements of the study, and signed informed consent or assent from child where appropriate. Patients < 18 years of age at baseline who are legally considered to be adults according to national legislation must consent in their own right if required by national legislation. Exclusion Criteria:

- Patients who have received investigational drugs or licensed treatments with anti HBV

activity (e. g., interferons [IFNs], lamivudine, tenofovir, emtricitabine, adefovir, entecavir, telbivudine, systemic acyclovir, systemic famciclovir) (Exception: Patients who have had a limited [ - Patients who have participated in any other clinical trial or who have received any

investigational drug within 6 months prior to baseline

- Known hypersensitivity to IFN, Pegasys or lamivudine

- Body surface area (BSA) < 0. 51 m2 based on Mosteller formula

- Positive test results at screening for hepatitis A virus IgM Ab, anti-HCV Ab,

anti-HDV Ab or anti-HIV Ab

- History or other evidence of bleeding from esophageal varices

- Decompensated liver disease (e. g., Child-Pugh Class B or C clinical classification or

clinical evidence such as ascites or varices)

- Advanced fibrosis or cirrhosis

- Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal

ultrasound within 6 months prior to baseline)

- History or other evidence of a medical condition associated with chronic liver

disease other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's disease or alpha-1 anti-trypsin deficiency

- Abnormal alfa-fetoprotein (AFP), neutrophil or platelet counts, hemoglobin levels, or

albumin/bilirubin levels

- Evidence of renal impairment

- History of immunologically mediated disease to include, but not limited to:

autoimmune hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or clinical evidence of rheumatoid arthritis

- Major depression or history of psychiatric disorder, such as major psychoses,

suicidal ideation, and/or suicide attempt, for which clinical trial participation would be inappropriate

- Evidence or history of chronic pulmonary or cardiac disease associated with

clinically significant functional limitation

- History of thyroid disease that was poorly controlled on prescribed medications, or

clinically relevant abnormal thyroid function tests (thyroid-stimulating hormone [TSH], free triiodothyronine [FT3], free thyroxin [FT4], thyroid peroxidase [TPO] antibodies, and TBG) at screening

- Poorly controlled diabetes

- History of solid organ or bone marrow transplantation

- Evidence of an active or suspected cancer or a history of malignancy in which the

risk of recurrence was/is > 20% within 2 years

- History of having received any systemic anti-neoplastic (including radiation) or

immunomodulatory treatment (including systemic corticosteroids) - Coagulopathy (screening international normalized ratio > 1. 5), hemoglobinopathy,

hemophilia, or history of severe illness or other blood disorders that would make patient unsuitable for the study

- History of seizure disorder requiring treatment with anticonvulsant medication

(excluding febrile seizures)

- History or other evidence of severe retinopathy

- History or other evidence of severe illness or any other conditions that would make

the patient, in the opinion of the investigator, unsuitable for the study

- Active substance abuse within 6 months prior to screening

- Sexually active females of childbearing potential and sexually active males who are

not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment

- Females who are pregnant or who are breastfeeding (females of childbearing potential

who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)

Locations and Contacts

Reference Study ID Number: NV25361 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Santo Domingo 10101, Dominican Republic; Not yet recruiting

Cairo 11566, Egypt; Not yet recruiting

Cairo, Egypt; Not yet recruiting

Menoufiya 32511, Egypt; Not yet recruiting

Essen 45122, Germany; Not yet recruiting

Mainz 55131, Germany; Recruiting

M√ľnchen 80337, Germany; Recruiting

Wuppertal 42283, Germany; Recruiting

Ciudad de Guatemala 01001, Guatemala; Not yet recruiting

Hyderabad 12, India; Not yet recruiting

Maharashtra 400012, India; Not yet recruiting

New Delhi 110060, India; Not yet recruiting

Beer Sheva 8410101, Israel; Not yet recruiting

Haifa 31096, Israel; Not yet recruiting

Jerusalem 91031, Israel; Not yet recruiting

Bucharest 011743, Romania; Recruiting

Bucharest 021105, Romania; Recruiting

Cluj-Napoca 400177, Romania; Recruiting

Iasi 700309, Romania; Recruiting

Timisoara 300011, Romania; Recruiting

Moscow 115446, Russian Federation; Recruiting

Moscow 117997, Russian Federation; Not yet recruiting

Moscow 119991, Russian Federation; Not yet recruiting

Saint Petersburg 197022, Russian Federation; Not yet recruiting

Samara 443100, Russian Federation; Recruiting

Taipei 100, Taiwan; Recruiting

Taoyuan County 333, Taiwan; Recruiting

Ankara 06100, Turkey; Recruiting

Ankara 06500, Turkey; Recruiting

Dnipropetrovsk 49006, Ukraine; Not yet recruiting

Kyiv 04050, Ukraine; Not yet recruiting

Kyiv 01119, Ukraine; Not yet recruiting

Vinnytsia 21021, Ukraine; Not yet recruiting

Birmingham B4 6NH, United Kingdom; Recruiting

Leeds LS9 7AU, United Kingdom; Recruiting

London SE5 9RS, United Kingdom; Recruiting

London E11BB, United Kingdom; Recruiting

Kansas City, Missouri 64108, United States; Not yet recruiting

Additional Information

Starting date: December 2014
Last updated: August 17, 2015

Page last updated: August 23, 2015

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