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Chronic Hepatitis BPhase 2NCT00226447

Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients

A Phase 2 study testing Pegylated Interferon and Lamivudine in people with Chronic Hepatitis B, run by Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance in chronic hepatitis B patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Pegylated Interferon and Lamivudine
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2002to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HBsAg positive for at least 6 months prior to screening
  • Serum HBV-DNA > 10^6 copies per ml at screening
  • Serum HBeAg positive at screening
  • Abnormal ALT (1.3-10x upper limit normal) within one month prior to entry
  • Compensated liver disease with the following minimum criteria:
  • Hemoglobin within range \& not less than 10% from lower normal limit
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  • WBC >= 4,000/mm3
  • Platelets >= 100,000/mm3
  • Bilirubin normal (except for Gilbert's disease).
  • Albumin stable and normal
  • Serum creatinine normal or not more than 10% above the upper normal limit
  • Thyroid Stimulating Hormone (TSH) within normal limits (Patients requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)
  • Alfa-fetoprotein in normal range (obtained within the previous year, or if elevated and < 500 ng/ml with a negative ultrasound for hepatocellular carcinoma at screening).
  • Written informed consent

Who cannot join

  • Co-infection with hepatitis C virus and/or HIV
  • Evidence or history of decompensated liver disease
  • Child's B cirrhosis
  • Ascites, bleeding varices, spontaneous encephalopathy
  • Hypersplenism (hemoglobin, white cell count, platelet outside inclusion criteria)
  • Coagulopathy (PT > 13 sec)
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  • Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the treatment such as:
  • Pre-existing psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.
  • Patients on anti-depressant therapy are excluded
  • CNS trauma or active seizure disorders requiring medication
  • Poorly controlled diabetes mellitus
  • Immunologically mediated disease (e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
  • Clinical gout
  • ANA > 1:320
  • documentation that women of childbearing potential are using contraception. A serum pregnancy test obtained within two weeks prior to initiation of treatment must be negative. Female patients must not be breast feeding.
  • Any known history of hypersensitivity to nucleoside analogues or interferon
  • Previous use of interferon, lamivudine, immunosuppressive drugs or corticosteroid
  • Subjects with clinically significant retinal abnormality
  • Substance abuse, such as alcohol (>80 g/day), iv drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded.
  • Subjects not willing to be counseled/abstain from the consumption of alcohol

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong SAR

Other trials in China

About this study

Official title: A Study on the Viral Kinetics of Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in HBeAg Positive Chronic Hepatitis B

The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance in chronic hepatitis B patients.

Read the detailed description

Chronic hepatitis B is a major cause of mortality and morbidity in Hong Kong and most Southeast Asian countries. The efficacy interferon-alfa (IFN-alfa) or lamivudine monotherapy is far from satisfactory with approximately 20% sustained viral response. Extended use of lamivudine is associated with the emergence of drug resistance mutants. As interferon is an immune modulator and lamivudine directly suppresses viral replication, it is therefore logical to combine the 2 drugs for more efficient viral clearance.

Previous studies on IFN-alfa and lamivudine combination treatment of chronic hepatitis B showed marginal benefit over lamivudine monotherapy. In these studies, lamivudine was either started 8 weeks prior to IFN-alfa or simultaneous with IFN-alfa. Recently, we have performed a study comparing the efficacy of polyethylene glycol-interferon alfa-2b (PEG-Intron A) and lamivudine versus lamivudine monotherapy for 1 year in the treatment of chronic hepatitis B. In our protocol, PEG-Intron A is started 8 weeks before the commencement of lamivudine, and PEG-Intron A is given for 32 weeks while lamivudine is given for a total of 52 weeks. Our published results suggested PEG-Intron A and lamivudine combination treatment is far superior to lamivudine monotherapy (end of treatment virological response 92% vs 20%, p=0.0015). We are not certain whether the benefit of PEG-Intron A and lamivudine combination in our study is due to our staggered regime, the superiority of PEG-Intron A over IFN-alfa, or both. The aim of this study is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance.

Being tested
Pegylated Interferon, Lamivudine
Keywords
Chronic Hepatitis B, Pegylated Interferon, Lamivudine
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HBV DNA reduction at week 52

Secondary outcomes (1)

  1. Normalization of ALT & negative HBV DNA at EOT, negative HBV DNA at EOT & 24 weeks after cessation of treatment, normalization of ALT at the end of treatment and 24 weeks after the cessation of treatment, Safety of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2005 (estimated)
  2. Study startDec 2002
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226447
Sponsor's protocol ID
P03227
Status last verified
Oct 2008
First submitted
23 Sep 2005
Last updated
24 Oct 2008
Results posted
No

Publications

  • Lok AS, Wu PC, Lai CL, Lau JY, Leung EK, Wong LS, Ma OC, Lauder IJ, Ng CP, Chung HT. A controlled trial of interferon with or without prednisone priming for chronic hepatitis B. Gastroenterology. 1992 Jun;102(6):2091-7. doi: 10.1016/0016-5085(92)90337-x.

    PubMed 1587429

  • Lai CL, Chien RN, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, Wu PC, Dent JC, Barber J, Stephenson SL, Gray DF. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. N Engl J Med. 1998 Jul 9;339(2):61-8. doi: 10.1056/NEJM199807093390201.

    PubMed 9654535

  • Leung NW, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, Lim SG, Wu PC, Dent JC, Edmundson S, Condreay LD, Chien RN; Asia Hepatitis Lamivudine Study Group. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology. 2001 Jun;33(6):1527-32. doi: 10.1053/jhep.2001.25084.

    PubMed 11391543

  • Schalm SW, Heathcote J, Cianciara J, Farrell G, Sherman M, Willems B, Dhillon A, Moorat A, Barber J, Gray DF. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial. Gut. 2000 Apr;46(4):562-8. doi: 10.1136/gut.46.4.562.

    PubMed 10716688

  • Barbaro G, Zechini F, Pellicelli AM, Francavilla R, Scotto G, Bacca D, Bruno M, Babudieri S, Annese M, Matarazzo F, Di Stefano G, Barbarini G; Lamivudine Italian Study Group Investigators. Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial. J Hepatol. 2001 Sep;35(3):406-11. doi: 10.1016/s0168-8278(01)00145-3.

    PubMed 11592603

  • Tsiang M, Rooney JF, Toole JJ, Gibbs CS. Biphasic clearance kinetics of hepatitis B virus from patients during adefovir dipivoxil therapy. Hepatology. 1999 Jun;29(6):1863-9. doi: 10.1002/hep.510290626.

    PubMed 10347131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated Interferon and Lamivudine in people with Chronic Hepatitis B, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBV DNA reduction at week 52. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00226447, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.

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