Hepatitis BPhase 2NCT00753467
A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B
A Phase 2 study testing IFN-γ 1b (Actimmune), Adefovir dipivoxil and IFN-γ 1b and Adefovir dipivoxil combination in people with Hepatitis B, run by Huntington Medical Research Institutes at 1 site in United States.
Trial summary
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- IFN-γ 1b (Actimmune), Adefovir dipivoxil and IFN-γ 1b and Adefovir dipivoxil combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
- Men or women age 18 to 75 years
- Chronic hepatitis B infection based on a history of positive anti-HBsAg and positive for HBV DNA and with or without elevations in liver tests (test to be repeated on screening)
Who cannot join
- Patients with any of the following will be excluded from randomization:
- Presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding
- Platelet count < 50,000/mm3
- Serum ALT level > 10 times upper limit of normal
- Alpha-fetoprotein level ≥ 200 ng/mL or alpha-fetoprotein level between 50-200 ng/mL in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
- Serum creatinine level > 1.6 mg/dL
Show all 38Show fewer
- Hematology outside of specified limits: neutrophil count <1000/mm3, hemoglobin <10 g/dL in males and <9 g/dL in females
- Unstable or uncontrolled thyroid disease
- Treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
- Presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
- Presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
- Chronic hepatitis C infection
- Hepatits Delta infection (HDV)
- Known history of HIV infection or positive HIV antibody test by Western Blot (test performed within 60 days of screening can be used to determine eligibility)
- A disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
- Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as oral prednisone, cyclosporine, azathioprine, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
- Behavior that suggests a significant risk of poor compliance including, but not limited to:
- Illicit drug abuse within the past 3 years
- Current or history of alcohol abuse within the past 2 years
- Prior treatment with IFN-γ 1b
- History of unstable or deteriorating cardiac disease, including but not limited to:
- Myocardial infarction, coronary artery bypass surgery, or angioplasty within the past 6 months
- Congestive heart failure requiring hospitalization within the past 6 months
- Uncontrolled arrhythmias
- Transient ischemic attacks (TIAs)
- Any cardiac condition that, in the opinion of the site PI, might be significantly exacerbated by flu-like symptoms associated with the administration of IFN γ 1b
- Preexisting (within last two years) or active psychiatric condition including severe depression, major psychoses, suicidal ideation or suicidal attempts
- History of (within last two years) or current neurologic or psychiatric disorder that, in the opinion of the site PI, might be exacerbated by flu-like symptoms associated with the administration of IFN γ 1b. In addition, patients with the following conditions should be excluded:
- History of multiple sclerosis
- Seizures within the past 2 years
- Severe or poorly controlled diabetes
- Pregnancy or lactation. Females of childbearing potential are required to have a negative urine pregnancy test prior to treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
- Hemoglobinopthies (e.g. thalassemia, sickle cell disease)
- Any serious or chronic disease that, in the opinion of the Principal Investigator (PI), may affect the assessment of safety or efficacy parameters. This includes, but is not limited to, patients with malignancy who are receiving chemotherapy, chronic obstructive pulmonary disease or asthma requiring maintenance oral steroids, or active kidney disease
- Any condition which, in the opinion of the site PI, is likely to result in the death of the patient within the next year
- Patients who, in the opinion of the site PI, are not suitable candidates for enrollment or would not comply with the requirements of the study
- Patients who have had a liver transplant
- Patients who have Adefovir mutations on baseline tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntington Medical Research Institutes
Pasadena, California, 91105
Lori Tong, RN, 626-397-5827, ltong@hmri.org
Myron J Tong, PhD, MD
About this study
Official title: Protocol Title: A Phase II Open-labeled Study to Determine the Safety and Preliminary Efficacy of Interferon-gamma 1b (IFN-γ 1b) in Patients With Chronic Hepatitis B Who Are HBV DNA Positive
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.
Read the detailed description
After signing the informed consent potential patients will undergo a screening medical history, physical examination, and laboratory tests.
The study will consist of two parts:
- Part A: IFN-γ 1b monotherapy
- Part B: IFN-γ 1b combination therapy with Adefovir dipivoxil or Adefovir dipivoxil monotherapy
Patients will be enrolled sequentially into to one of three treatment groups. In Part A, ten patients will be enrolled and will receive IFN-γ 1b 200μg, administered every day by subcutaneous injection for 4 weeks. If HBV DNA is reduced by ≥ 1 log10 copies/ mL in ≥ 30% of patients the protocol will proceed to Part B.
In Part B, twenty patients will be enrolled into two cohorts (total of 10 for each cohort) and treated for four weeks. The two cohorts will be administered:
- IFN-γ 1b 200μg, administered every day combination therapy with Adefovir dipivoxil (10mg QD) or
- Adefovir dipivoxil (10mg QD) alone
On the initial study visit, patients will be given instruction on self injection of IFN-γ 1b (if applicable). Patients will be monitored for safety, tolerability, HBV DNA, clinical chemistries including a standard panel of liver tests and hematologies throughout the study and for the two week post-treatment observation period.
- Conditions
- Hepatitis B
- Being tested
- IFN-γ 1b (Actimmune), Adefovir dipivoxil, IFN-γ 1b and Adefovir dipivoxil combination
- Keywords
- HBV, Treatment, Interferon-gamma, combination, Hepsera, Actimmune, HBV DNA
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN-γ 1b (Actimmune)Drug
Also called Interferon gamma, Actimmune, Immune Interferon, IFN-gamma
IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose
Adefovir dipivoxilDrug
Also called Hepsera
Adefovir dipivoxil: 1 tablet of 10mg given orally QD
IFN-γ 1b and Adefovir dipivoxil combinationDrug
Also called Actimmune, Interferon gamma, IFN gamma, Immune Interferon
IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose Adefovir dipivoxil: 1 tablet of 10mg given orally QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days Receives: Drug: IFN-γ 1b (Actimmune) |
| 2 | Experimental | IFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days Receives: Drug: IFN-γ 1b and Adefovir dipivoxil combination |
| 3 | Active comparator | Adefovir dipivoxil monotherapy (10 mg QD) 30 days Receives: Drug: Adefovir dipivoxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Measured: 30 days
Secondary outcomes (2)
Evaluate the changes in serum HBV DNA concentrations following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Measured: 30 days
Evaluate the changes in liver tests and hematology following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huntington Medical Research Institutes
- Sponsor type
- University, hospital or other
- Collaborators
- InterMune
- Investigators
- Myron J Tong, Phd, MD, Study chair, HMRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753467
- Sponsor's protocol ID
- TONG-HBV-0801
- Status last verified
- Sep 2008
- First submitted
- 15 Sep 2008
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parvez MK, Sehgal D, Sarin SK, Basir SF, Jameel S. Inhibition of hepatitis B virus DNA replicative intermediate forms by recombinant interferon-gamma. World J Gastroenterol. 2006 May 21;12(19):3006-14. doi: 10.3748/wjg.v12.i19.3006.
PubMed 16718779Lau JY, Lai CL, Wu PC, Chung HT, Lok AS, Lin HJ. A randomised controlled trial of recombinant interferon-gamma in Chinese patients with chronic hepatitis B virus infection. J Med Virol. 1991 Jul;34(3):184-7. doi: 10.1002/jmv.1890340310.
PubMed 1919540Marcellin P, Loriot MA, Boyer N, Martinot-Peignoux M, Degott C, Degos F, Brandely M, Lenfant B, Benhamou JP. Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and biological effects. Hepatology. 1990 Jul;12(1):155-8. doi: 10.1002/hep.1840120124.
PubMed 2115494Narayan R, Buronfosse T, Schultz U, Chevallier-Gueyron P, Guerret S, Chevallier M, Saade F, Ndeboko B, Trepo C, Zoulim F, Cova L. Rise in gamma interferon expression during resolution of duck hepatitis B virus infection. J Gen Virol. 2006 Nov;87(Pt 11):3225-3232. doi: 10.1099/vir.0.82170-0.
PubMed 17030856Wang J, Michalak TI. Inhibition by woodchuck hepatitis virus of class I major histocompatibility complex presentation on hepatocytes is mediated by virus envelope pre-S2 protein and can be reversed by treatment with gamma interferon. J Virol. 2006 Sep;80(17):8541-53. doi: 10.1128/JVI.00830-06.
PubMed 16912304Wieland SF, Eustaquio A, Whitten-Bauer C, Boyd B, Chisari FV. Interferon prevents formation of replication-competent hepatitis B virus RNA-containing nucleocapsids. Proc Natl Acad Sci U S A. 2005 Jul 12;102(28):9913-7. doi: 10.1073/pnas.0504273102. Epub 2005 Jul 1.
PubMed 15994231Park SG, Ryu HM, Lim SO, Kim YI, Hwang SB, Jung G. Interferon-gamma inhibits hepatitis B virus-induced NF-kappaB activation through nuclear localization of NF-kappaB-inducing kinase. Gastroenterology. 2005 Jun;128(7):2042-53. doi: 10.1053/j.gastro.2005.03.002.
PubMed 15940636Bissett J, Eisenberg M, Gregory P, Robinson WS, Merigan TC. Recombinant fibroblast interferon and immune interferon for treating chronic hepatitis B virus infection: patients' tolerance and the effect on viral markers. J Infect Dis. 1988 May;157(5):1076-80. doi: 10.1093/infdis/157.5.1076. No abstract available.
PubMed 3129521Porres JC, Mora I, Gutiez J, Bartolome J, Quiroga JA, Bas C, Compernolle C, Ordi J, Chocarro A, Carreno V. Antiviral effect of recombinant gamma interferon in chronic hepatitis B virus infection: a pilot study. Hepatogastroenterology. 1988 Feb;35(1):5-9.
PubMed 2452123Di Bisceglie AM, Rustgi VK, Kassianides C, Lisker-Melman M, Park Y, Waggoner JG, Hoofnagle JH. Therapy of chronic hepatitis B with recombinant human alpha and gamma interferon. Hepatology. 1990 Feb;11(2):266-70. doi: 10.1002/hep.1840110217.
PubMed 2106474
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Title: A Phase II Open-labeled Study to Determine the Safety and Preliminary Efficacy of Interferon-gamma 1b (IFN-γ 1b) in Patients With Chronic Hepatitis B Who Are HBV DNA Positive
- ClinicalTrials.gov ID
- NCT00753467
- Acronym / sponsor ID
- TONG-HBV-0801
- Conditions
- Hepatitis B
- Keywords
- HBV, Treatment, Interferon-gamma, combination, Hepsera, Actimmune, HBV DNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huntington Medical Research InstitutesUniversity, hospital or other
- Collaborators
- InterMune
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.
Detailed description
After signing the informed consent potential patients will undergo a screening medical history, physical examination, and laboratory tests.
The study will consist of two parts:
- Part A: IFN-γ 1b monotherapy
- Part B: IFN-γ 1b combination therapy with Adefovir dipivoxil or Adefovir dipivoxil monotherapy
Patients will be enrolled sequentially into to one of three treatment groups. In Part A, ten patients will be enrolled and will receive IFN-γ 1b 200μg, administered every day by subcutaneous injection for 4 weeks. If HBV DNA is reduced by ≥ 1 log10 copies/ mL in ≥ 30% of patients the protocol will proceed to Part B.
In Part B, twenty patients will be enrolled into two cohorts (total of 10 for each cohort) and treated for four weeks. The two cohorts will be administered:
- IFN-γ 1b 200μg, administered every day combination therapy with Adefovir dipivoxil (10mg QD) or
- Adefovir dipivoxil (10mg QD) alone
On the initial study visit, patients will be given instruction on self injection of IFN-γ 1b (if applicable). Patients will be monitored for safety, tolerability, HBV DNA, clinical chemistries including a standard panel of liver tests and hematologies throughout the study and for the two week post-treatment observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IFN-γ 1b (Actimmune)IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days |
| 2 | Experimental | Drug: IFN-γ 1b and Adefovir dipivoxil combinationIFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days |
| 3 | Active comparator | Drug: Adefovir dipivoxilAdefovir dipivoxil monotherapy (10 mg QD) 30 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
- Men or women age 18 to 75 years
- Chronic hepatitis B infection based on a history of positive anti-HBsAg and positive for HBV DNA and with or without elevations in liver tests (test to be repeated on screening)
Key exclusion criteria (38 listed)
- Presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding
- Platelet count < 50,000/mm3
- Serum ALT level > 10 times upper limit of normal
- Alpha-fetoprotein level ≥ 200 ng/mL or alpha-fetoprotein level between 50-200 ng/mL in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
- Serum creatinine level > 1.6 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFN-γ 1b (Actimmune)Also: Interferon gamma, Actimmune, Immune Interferon, IFN-gammaIFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose | Drug | 1 |
| Adefovir dipivoxilAlso: HepseraAdefovir dipivoxil: 1 tablet of 10mg given orally QD | Drug | 3 |
| IFN-γ 1b and Adefovir dipivoxil combinationAlso: Actimmune, Interferon gamma, IFN gamma, Immune InterferonIFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose Adefovir dipivoxil: 1 tablet of 10mg given orally QD | Drug | 2 |
Primary outcome
The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Time frame: 30 days
2 secondary outcomes
Evaluate the changes in serum HBV DNA concentrations following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Time frame: 30 days
Evaluate the changes in liver tests and hematology following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
- Background: PubMed 16718779Parvez MK, Sehgal D, Sarin SK, Basir SF, Jameel S. Inhibition of hepatitis B virus DNA replicative intermediate forms by recombinant interferon-gamma. World J Gastroenterol. 2006 May 21;12(19):3006-14. doi: 10.3748/wjg.v12.i19.3006.
- Background: PubMed 1919540Lau JY, Lai CL, Wu PC, Chung HT, Lok AS, Lin HJ. A randomised controlled trial of recombinant interferon-gamma in Chinese patients with chronic hepatitis B virus infection. J Med Virol. 1991 Jul;34(3):184-7. doi: 10.1002/jmv.1890340310.
- Background: PubMed 2115494Marcellin P, Loriot MA, Boyer N, Martinot-Peignoux M, Degott C, Degos F, Brandely M, Lenfant B, Benhamou JP. Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and biological effects. Hepatology. 1990 Jul;12(1):155-8. doi: 10.1002/hep.1840120124.
- Results publication: PubMed 17030856Narayan R, Buronfosse T, Schultz U, Chevallier-Gueyron P, Guerret S, Chevallier M, Saade F, Ndeboko B, Trepo C, Zoulim F, Cova L. Rise in gamma interferon expression during resolution of duck hepatitis B virus infection. J Gen Virol. 2006 Nov;87(Pt 11):3225-3232. doi: 10.1099/vir.0.82170-0.
- Results publication: PubMed 16912304Wang J, Michalak TI. Inhibition by woodchuck hepatitis virus of class I major histocompatibility complex presentation on hepatocytes is mediated by virus envelope pre-S2 protein and can be reversed by treatment with gamma interferon. J Virol. 2006 Sep;80(17):8541-53. doi: 10.1128/JVI.00830-06.
- Results publication: PubMed 15994231Wieland SF, Eustaquio A, Whitten-Bauer C, Boyd B, Chisari FV. Interferon prevents formation of replication-competent hepatitis B virus RNA-containing nucleocapsids. Proc Natl Acad Sci U S A. 2005 Jul 12;102(28):9913-7. doi: 10.1073/pnas.0504273102. Epub 2005 Jul 1.
- Results publication: PubMed 15940636Park SG, Ryu HM, Lim SO, Kim YI, Hwang SB, Jung G. Interferon-gamma inhibits hepatitis B virus-induced NF-kappaB activation through nuclear localization of NF-kappaB-inducing kinase. Gastroenterology. 2005 Jun;128(7):2042-53. doi: 10.1053/j.gastro.2005.03.002.
- Results publication: PubMed 3129521Bissett J, Eisenberg M, Gregory P, Robinson WS, Merigan TC. Recombinant fibroblast interferon and immune interferon for treating chronic hepatitis B virus infection: patients' tolerance and the effect on viral markers. J Infect Dis. 1988 May;157(5):1076-80. doi: 10.1093/infdis/157.5.1076. No abstract available.
- Results publication: PubMed 2452123Porres JC, Mora I, Gutiez J, Bartolome J, Quiroga JA, Bas C, Compernolle C, Ordi J, Chocarro A, Carreno V. Antiviral effect of recombinant gamma interferon in chronic hepatitis B virus infection: a pilot study. Hepatogastroenterology. 1988 Feb;35(1):5-9.
- Results publication: PubMed 2106474Di Bisceglie AM, Rustgi VK, Kassianides C, Lisker-Melman M, Park Y, Waggoner JG, Hoofnagle JH. Therapy of chronic hepatitis B with recombinant human alpha and gamma interferon. Hepatology. 1990 Feb;11(2):266-70. doi: 10.1002/hep.1840110217.
- Huntington Medical Research InstitutesLink provided by the sponsor.
- Myron J. Tong, PhD, MDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron J Tong, Phd, MD study chair
HMRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IFN-γ 1b (Actimmune), Adefovir dipivoxil and IFN-γ 1b and Adefovir dipivoxil combination in people with Hepatitis B, run by Huntington Medical Research Institutes at 1 site in United States.
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 3 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 21 Oct 2010. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B. (time frame: 30 days). 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 NCT00753467, which also lists 10 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 21 Oct 2010.