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

NCT02201407 | Completed

• 1 other identifier: ML29062
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

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).

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion

  Week 72

• Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response

  Week 48

• Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response

  Week 48

• Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs

  Up to 72 weeks

Study Arms (1)

CHB Participants Treated With Peginterferon alfa-2a

As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with local labeling and not directed by the protocol. Participants with CHB who are receiving peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics, and in line with the local labeling will be followed for the duration of treatment with peginterferon alfa-2a (48 weeks) and up to 24 weeks after peginterferon alfa-2a treatment (72 weeks in total).

Drug: Peginterferon alfa-2a

Interventions

Peginterferon alfa-2a DRUG

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

Also known as: PEGASYS

CHB Participants Treated With Peginterferon alfa-2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Clinic for Gastroenterology and Hepatology

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia; Institute For Infectious Diseases

Belgrade, 11000, Serbia

Location

Clinical Center Zemun

Belgrade, 11080, Serbia

Location

Clinic for Infectious Diseases CC Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic for Infectious Diseases CC Nis

Niš, 18000, Serbia

Location

Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 28, 2014
• Study Start: December 18, 2014
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

SE (6)