An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201407
• Other study ID #: ML29062
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: August 30, 2017
• Start date: December 18, 2014
• Est. completion date: April 10, 2017

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.

Locations

Country	Name	City	State
Serbia	Clinic for Gastroenterology and Hepatology	Belgrade
Serbia	Clinical Center of Serbia; Institute For Infectious Diseases	Belgrade
Serbia	Clinical Center Zemun	Belgrade
Serbia	Clinic for Infectious Diseases CC Kragujevac	Kragujevac
Serbia	Clinic for Infectious Diseases CC Nis	NIS
Serbia	Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control	Sustained immune control is defined as a combined response: post-treatment HBeAg seroconversion, and HBV deoxyribonucleic acid (DNA) levels less than (<) 2000 international units per milliliter (IU/mL), and alanine aminotransferase (ALT) normalization.	Week 72
Primary	Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control	Sustained immune control is defined as a combined response: HBV DNA levels <2000 IU/mL and ALT normalization.	Week 72
Secondary	Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion		Week 72
Secondary	Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response	Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels <2000 IU/mL, and ALT normalization.	Week 48
Secondary	Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response	Combined response is defined as: HBV DNA levels <2000 IU/mL and ALT normalization.	Week 48
Secondary	Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs		Up to 72 weeks