DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: pegylated Interferon-alpha 2a (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Yonsei University

Official(s) and/or principal investigator(s):
Sang Hoon Ahn, MD. PhD, Study Chair, Affiliation: Department of Internal Medicine, Yonsei Universtiy College of Medicine,

Overall contact:
Young Eun Chon, MD, Phone: 02-2228-1936, Email: NACHIVYS@yuhs.ac

Summary

The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys« therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys« therapy in patients with CHB.

Clinical Details

Official title: An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys«): TRACES STUDY

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys

Secondary outcome:

Sustained suppression of HBV DNA

HBeAg loss and seroconversion in HBeAg-positive CHB

ALT normalization

Detailed description:

- Korea is known to be an endemic area for HBV infection. Some studies have reported that

more than 95% of patients in Korea with chronic HBV have genotype C infection.

- Compared with other genotypes, genotype C is associated with increased viral loads,

higher histologic activity, more severe acute exacerbations, a longer viral clearance phase and worse antiviral response to peg-interferon therapy.

- Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B

(CHB) patients with compensated and decompensated liver disease. However, a possibility of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA levels after termination of NAs administration. In addition, NA therapy has been reported to have lower chance of HBsAg seroclearance compared to that with immunomodulatory agents such as peginterferon.

- Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease.

However, a better understanding of HBV treatment with Pegasys® in the real-life clinical setting in Korea can be helpful for decision of treatment strategy in the future. Asian experience with Pegasys® therapy in CHB is limited. Study populations of investigator-initiated trials consist of selected group with smaller number of Korean patients. Therefore, long-term efficacy and safety data in real practice with Pegasys®

treatment in both HBeAg-positive and - negative Korean patients are necessary.

- In addition, the current proposed collected data study may be helpful to bring answers

to many unresolved issues: the antiviral efficacy and safety profiles in Korean CHB patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult subjects receiving treatment for CHB with PEGASYS according to standard of care

and in line with the current summary of product characteristics(SPC)/ local labeling who have no contra-indication to PEGASYS therapy as per the local label.

- Adult chronic hepatitis B patients (20 years of age or older) who has been completed

or are currently receiving or are planned to receive Pegasys® as a first-line therapy.

- Those with baseline HBV DNA > 2,000 IU/mL and elevation of ALT level.

- HBeAg positive or HBeAg negative serologically proven chronic hepatitis B(CHB)

- Subjects treated with previous NAs therapy are eligible for this study.

Exclusion Criteria: Subjects with ALT > 10 x ULN or evidence of hepatocellular carcinoma.

- Subjects should be without serological evidence of co-infection with HCV, HIV, or

HDV.

- Subjects with decompensated liver disease, as well as pregnant or breast-feeding

women, will not be eligible for the study.

- Subjects should have no other diseases that might be contraindication to

peg-interferon therapy as per local SPC (e. g., severe psychiatric diseases, immunological diseases, severe retinopathy or thyroid dysfunction, history of severe pre-existing cardiac disease, etc)

- Subjects with other contra-indications to PEGASYS therapy as detailed in the label

(hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)

- A history of liver transplantation or planned for liver transplantation

- Subjects who receive concomitant therapy with telbivudine.

Locations and Contacts

Young Eun Chon, MD, Phone: 02-2228-1936, Email: NACHIVYS@yuhs.ac

Sang Hoon Ahn, Seoul, Seodaemun-gu 120-752, Korea, Republic of; Recruiting
Young Eun Chon, MD, Email: NACHIVYS@yuhs.ac
Additional Information

Starting date: January 2012
Last updated: February 22, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017