Status:
COMPLETED
An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB). ...
Eligibility Criteria
Inclusion
- HBeAg positive or HBeAg negative serologically proven CHB with or without cirrhosis (histologically verified at some point in the past)
- Baseline HBV DNA greater than (\>) 2000 IU/mL
- Elevated serum ALT \> upper limit of normal (ULN)
- Participants treated with previous NAs therapy are eligible for this study
Exclusion
- Participants who have contraindications for peginterferon alfa-2a in accordance with the approved summary of product characteristics (for example, severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
- Participants with ALT \> 10 times of ULN or evidence of hepatocellular carcinoma
- Participants with serological evidence of co-infection with hepatitis A virus, hepatitis C virus, human immunodeficiency virus, or hepatitis D virus
- Participants with decompensated liver disease
- Pregnant or breast-feeding women
- A history of liver transplantation or planned for liver transplantation
Key Trial Info
Start Date :
December 18 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02201407
Start Date
December 18 2014
End Date
April 10 2017
Last Update
August 31 2017
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinic for Gastroenterology and Hepatology
Belgrade, Serbia, 11000
2
Clinical Center of Serbia; Institute For Infectious Diseases
Belgrade, Serbia, 11000
3
Clinical Center Zemun
Belgrade, Serbia, 11080
4
Clinic for Infectious Diseases CC Kragujevac
Kragujevac, Serbia, 34000