S-Collate

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RS International Santosa, Bandung; RS PGI Cikini, Jakarta; RS Borromeus, Bandung; Klinik Kimia Farma, Jakarta; RS Medistra Jakarta; Klinik Hati, Jakarta; RS Mitra International Jatinegara, Jakarta; RS Cipto Mangunkusumo, Jakarta; RS Dr. Soetomo, Surabaya; RS Hasan Sadikin, Bandung; RS International Bintaro, Tangerang.
No Registry
INA-ODE8ELW
Tanggal Input Registry : 29-09-2017

26-08-2009
To assess in routine clinical practice on-treatment predictors of HBsAg clearance in subjects with HBeAg positive or negative chronic hepatitis B virus infection (CHB) receiving therapy with Peginterferon alfa-2a (PEG IFN) and followed for up to 3 years after treatment cessation.
Evaluation of the incidence of sustained suppression of HBV DNA In subjects with HBeAg positive CHB: incidence of HBeAg seroconversion Evaluation of the incidence of normalization of serum ALT To assess in routine clinical practice pre-treatment predictors of HBsAg clearance in subjects with HBeAg positive or negative CHB who receive therapy with PEG IFN and are followed for up to 3 years To assess predictors of HBsAg seroconversion in subjects with HBeAg positive or negative CHB Evaluation of the incidence of clinical endpoints, where data available, in responders versus non-responders to treatment: Death, transplantation, HCC, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline)
 
S-Collate
A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects with HBeAg positive and HBeAg negative Chronic Hepatitis B Receiving Therapy with PEGASYS(R) (Peginterferon alfa-2a 40KD)
Observasional
All clinical information and laboratory parameters documented for this observational study prior to start of PEG IFN treatment and during this study were routinely assessed as SOC and not for the purpose of this study. Patient’s medical history, demographics, and disease characteristics were extracted from the medical record, as well as the CHB treatment observations (dose and exposure), concomitant medication and AEs. To evaluate serological and virological treatment response the respective tests were done as routine procedures, test kits and frequency of measuring depending on SOC in the respective clinic/practice. Patients were observed for the duration of PEG IFN treatment and for up to 3 years afterwards.
1842
 

Inclusion Criteria:

Male and female subjects ≥18 years of age; HBeAg positive or HBeAg negative serologically proven CHB with or without cirrhosis; Elevated serum ALT >ULN (upper limit of normal) but ≤10 × ULN according to local label; Written informed consent where local regulations allow or require it.

Exclusion Criteria:

Subjects with no contra-indications to PEG IFN therapy as detailed in the label (hypersensitivity to the active substance, to alpha interferons, or to any of the excipients; autoimmune hepatitis; severe hepatic dysfunction or decompensated cirrhosis of the liver; a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months)  Subjects who were not co-infected with HAV, HCV or HIV  Subjects were not to receive concomitant therapy with telbivudine (because concomitant peginterferon therapy is contraindicated according to the telbivudine label)  Female subjects not pregnant or breast feeding when PEG IFN treatment commenced, and aware of the requirement to use an effective method of contraception during therapy
 
Komite Etik Fakultas Kedokteran Universitas Indonesia, 240/PT02.FK/ETIK/2009, 06 Jul 2009
NA
PN.01.01.313.3.3627, 20 Oct 2009
MV22009
dr. H.R. Syarief H. Djajadiredja, SpPD-KGEH; Prof. dr. H. Nurul Akbar, SpPD-KGEH; dr. H.M. Begawan Bestari, SpPD-KGEH; dr. Unggul Budihusodo, SpPD-KGEH; Prof.dr. Laurentius A. Lesmana, MD, SpPD-KGEH, PhD; dr. Andri Sanitiyoso, SpPD-KGEH; Prof. dr. Sjaifoellah Noer, SpPD-KGEH; dr.Irsan Hasan, SpPD-KGEH; dr.Poernomo Boedi, SpPD-KGEH; dr. Ali Djumhana, SpPD-KGEH; Dr. dr. Rino Alvani Gani, SpPD-KGEH.