A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00927082
First received: June 16, 2009
Last updated: February 10, 2016
Last verified: February 2016
  Purpose
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.

  • Percentage of Participants With HBsAg Loss [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.


Secondary Outcome Measures:
  • Percentage of Participants With HBeAg Loss. [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.

  • Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion. [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.

  • Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe). [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.

  • Percentage of Participants With Presence of Anti-HBs [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.

  • Percentage of Participants With Normalised Alanine Transaminase (ALT) [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.

  • Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL). [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

  • Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL) [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

  • Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL) [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.

  • Quantitative HBsAg [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
    Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.

  • Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B [ Time Frame: Up to 5-year FU period ] [ Designated as safety issue: No ]
    Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.

  • Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB) [ Time Frame: Up to 5-year FU period ] [ Designated as safety issue: Yes ]
    Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).

  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to 5-year FU period ] [ Designated as safety issue: Yes ]
    Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430


Enrollment: 383
Study Start Date: April 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-IFN 90mcg 24 Wks
Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
Drug: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
Experimental: PEG-IFN 180mcg 24 Wks
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
Drug: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
Experimental: PEG-IFN 90mcg 48 Wks
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Drug: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
Experimental: PEG-IFN 180mcg 48 Wks
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Drug: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent for Study WV19432
  • Patients who have completed treatment and follow-up on study WV19432

Exclusion Criteria:

  • As for Study WV19432
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927082

  Hide Study Locations
Locations
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Brazil
Salvador, BA, Brazil, 40210-341
Campinas, SP, Brazil, 13083-888
Ribeirao Preto, SP, Brazil, 14049-900
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 05403-000
China
Beijing, China, 100054
Beijing, China, 100050
Changsha, China, 410008
Guangzhou, China, 510630
Shanghai, China, 200025
Shanghai, China, 201508
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
New Zealand
Auckland, New Zealand, 100
Hamilton, New Zealand
Russian Federation
Samara, Russian Federation, 443100
St Petersburg, Russian Federation, 190103
Stavropol, Russian Federation, 355017
Singapore
Singapore, Singapore, 169608
Taiwan
Kaohsiung, Taiwan, 807
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiang Mai, Thailand, 50202
Khon Kaen, Thailand, 40002
Songkhla, Thailand, 90112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00927082     History of Changes
Other Study ID Numbers: MV22430 
Study First Received: June 16, 2009
Results First Received: February 10, 2016
Last Updated: February 10, 2016
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2016