Clinical trial NCT02201407: An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study
Official title: Open, Multicenter, Local, Non-Randomized, Non-Interventional Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40kD) - PRO B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants receiving treatment for CHB with peginterferon alfa-2a according to standard of care and in line with the current summary of product characteristics and local labeling who have no contraindication to peginterferon alfa-2a therapy as per the local label. Target population are naïve participants (who have never received any HBV treatment) and previously treated participants with NAs.

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). Participants who have never received any hepatitis B virus (HBV) treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care treatment) and for up to 24 weeks thereafter (72 weeks in total).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control
timeFrame: Week 72
measure: Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion
timeFrame: Week 72
measure: Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response
timeFrame: Week 48
measure: Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response
timeFrame: Week 48
measure: Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for Gastroenterology and Hepatology
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia; Institute For Infectious Diseases
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: Clinic for Infectious Diseases CC Kragujevac
city: NIS
country: Serbia
facility: Clinic for Infectious Diseases CC Nis
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: