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Completed

NCT Number: NCT01787279

An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B

This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Casablanca, Morocco

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 and </= 70 years of age
  • HBeAg-negative chronic hepatitis B
  • HBsAg-positive for at least 6 months, anti- hepatitis B (HBs) negative
  • Serum alanine transaminase (ALT) > 2 ULN (upper limit of normal) but </= 10 x Upper limit of normal (ULN)
  • Hepatitis B virus (HBV) DNA > 10'000 copies/ml (Roche Monitor or Taqman)
  • No previous treatment with interferon (standard or pegylated) or with a nucleoside analogue
  • Women of childbearing potential must agree to use reliable contraception during the study and for 3 months after treatment completion

Exclusion criteria

  • Previous antiviral interferon-based therapy for chronic hepatitis B
  • Pregnant and lactating women
  • Evidence of decompensated liver disease
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
  • Previous or current hepatocellular carcinoma
  • History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease
  • Inadequate hematologic or renal function
  • Serum bilirubin level > 2 times the upper limit of normal
  • Severe psychiatric disease
  • History of severe seizure disorder or current anticonvulsant use
  • History of evidence of any disease or condition which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Evidence of drug abuse within one year of study entry
  • Alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks per day for women (1 standard drink contains 10 g of alcohol)
  • Participation in another trial or receipt of an investigational drug within 12 weeks prior to screening

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 mcg subcutaneously weekly, 48 weeks

Primary outcomes

  1. Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72

    Time frame: At Week 72

    Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.

  2. Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72

    Time frame: At Week 72

    Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.

  3. Number of Participants With Any Adverse Events and Serious Adverse Events

    Time frame: Up to Week 72

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above

Secondary outcomes

  1. Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72

    Time frame: At Week 72

    Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.

  2. Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48

    Time frame: At Screening and Week 48

    Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.

  3. Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72

    Time frame: At Week 72

    Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Expanded Access Programme of PEGASYS® (Peg Interferon Alpha-2a 40KD) in Patients With HBe-Ag-negative Chronic Hepatitis B

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2013
Registry last updated
Jul 22, 2016

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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