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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
Morocco
Study Type
Interventional
Intervention
Peginterferon alfa-2a [Pegasys]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peginterferon alpha-2a, 180 mcg/48 weeks

Arm Description

Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter 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.
Percentage of Participants Achieving Normalization of Alanine Aminotransferase 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.
Number of Participants With Any Adverse Events and Serious Adverse Events
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 Outcome Measures

Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72
Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion 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.
Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72
Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.

Full Information

First Posted
February 6, 2013
Last Updated
June 10, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01787279
Brief Title
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Official Title
Expanded Access Programme of PEGASYS® (Peg Interferon Alpha-2a 40KD) in Patients With HBe-Ag-negative Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon alpha-2a, 180 mcg/48 weeks
Arm Type
Experimental
Arm Description
Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg subcutaneously weekly, 48 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72
Description
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.
Time Frame
At Week 72
Title
Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72
Description
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.
Time Frame
At Week 72
Title
Number of Participants With Any Adverse Events and Serious Adverse Events
Description
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
Time Frame
Up to Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72
Description
Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.
Time Frame
At Week 72
Title
Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48
Description
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.
Time Frame
At Screening and Week 48
Title
Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72
Description
Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.
Time Frame
At Week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Casablanca
ZIP/Postal Code
20100
Country
Morocco
City
Casablanca
Country
Morocco
City
Rabat
ZIP/Postal Code
504
Country
Morocco
City
Rabat
ZIP/Postal Code
62000
Country
Morocco

12. IPD Sharing Statement

Learn more about this trial

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

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