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NCT Number: 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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Gastroenterology and Hepatology, Belgrade, Serbia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PEGASYS

Primary outcomes

  1. Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control

    Time frame: Week 72

    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.

  2. Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control

    Time frame: Week 72

    Sustained immune control is defined as a combined response: HBV DNA levels <2000 IU/mL and ALT normalization.

Secondary outcomes

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

    Time frame: Week 72

  2. Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response

    Time frame: Week 48

    Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels <2000 IU/mL, and ALT normalization.

  3. Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response

    Time frame: Week 48

    Combined response is defined as: HBV DNA levels <2000 IU/mL and ALT normalization.

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

    Time frame: Up to 72 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2014
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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