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
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00927082
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
- Informed consent for Study WV19432
- Patients who have completed treatment and follow-up on study WV19432
- As for Study WV19432
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-IFN 90mcg 24 Wks peginterferon alfa-2a [Pegasys] 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. PEG-IFN 180mcg 24 Wks peginterferon alfa-2a [Pegasys] Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430. PEG-IFN 90mcg 48 Wks peginterferon alfa-2a [Pegasys] Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430. PEG-IFN 180mcg 48 Wks peginterferon alfa-2a [Pegasys] Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. Annually, for up to 5 years 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 Annually, for up to 5 years 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
Name Time Method Percentage of Participants With HBeAg Loss. Annually, for up to 5 years 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. Annually, for up to 5 years 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). Annually, for up to 5 years 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 Annually, for up to 5 years 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) Annually, for up to 5 years 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). Annually, for up to 5 years 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) Annually, for up to 5 years 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) Annually, for up to 5 years 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 Annually, for up to 5 years 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 Up to 5-year FU period 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) Up to 5-year FU period 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 Up to 5-year FU period 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