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Hepatitis CPhase 1NCT00277758

Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

A Phase 1 study testing Interleukin 2, Ribavirin and Pegylated Interferon Alpha in people with Hepatitis C, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
Interleukin 2, Ribavirin and Pegylated Interferon Alpha
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Mar 2004to Aug 2006
Phase
Phase 1
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

  • Men and women, age >18 years to < 65 years.
  • Ability and willingness to sign an informed consent.
  • Hepatitis C antibody positive status confirmed by the NYPH laboratory.
  • Genotype 1 HCV confirmed by the NYPH laboratory using the DupliType assay as performed by Quest Diagnostics.
  • Liver biopsy demonstrating chronic hepatitis but without cirrhosis within 2 years of enrollment.
  • Prothrombin time < 3 seconds longer than control.
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  • Platelet count ≥75,000 mm3
  • Neutrophil count ≥ 1000/mm3
  • Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men
  • Subject must agree not to participate in a conception process (defined as active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization etc.) while on study drugs and for 6 months following permanent discontinuation of study therapy.
  • Women of reproductive potential (defined for this study as sexually mature women who have not been post-menopausal for at least 24 consecutive months, or have not undergone hysterectomy or oophorectomy) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 MIU/mL performed within 30 days prior to enrollment and again within 24 hours before initiating study therapy.
  • All subjects must not participate in a conception process, and if participating in sexual activity that could lead to pregnancy, male subjects must take every precaution to avoid risk of pregnancy for their female partners, women subjects/male partners must use two reliable methods of contraception simultaneously, while receiving study therapy and for 6 months following permanent discontinuation of study therapy.
  • NOTE A: Reliable forms of contraception are a combination of two of the following methods: 1) condoms (male or female) with or without a spermicidal agent. 2) diaphragm or cervical cap with spermicide, 3) IUD, or 4) hormonal-based contraception.
  • NOTE B: An IUD is an adequate method of contraception but increases the risk of pelvic inflammatory disease.

Who cannot join

  • Previous IFN-alpha, RBV or IL2 therapy
  • Any active viral hepatitis other than hepatitis C virus infection, as defined by the presence of IgM antibody to Hepatitis A Virus (HAV) within 30 days of enrollment, or Hepatitis B Virus Surface Antigen (HBsAg) positivity, or positive plasma HBV DNA by PCR methodology when HB core antibody is the only serologic marker of HBV infection within 30 days of entry.
  • ALT and AST > 5x ULN, total bilirubin > 1.5 x ULN
  • Signs/symptoms of advanced liver disease.
  • Uncontrolled infection, except hepatitis C
  • HIV infection as determined by HIV ELISA \& Western blot assay, and confirmed by plasma HIV assay (PCR or bDNA)
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  • Cardiac condition that cannot be controlled by medication: Because of the risk of anemia associated with RBV use and the potential to induce cardiac ischemia, subjects with a positive cardiac stress test are ineligible. Therefore, subjects > 40 years of age with ≥ 1 risk factor for ASHD (i.e., hyperlipidemia, hypertension, smoking history, family history) should have an EKG preformed. If the EKG is abnormal and consistent with ischemic heart disease, the subject should have a cardiac stress test to R/O ASHD.
  • CNS or psychiatric illness uncontrolled by medication. In particular, psychiatric illness, especially depression. Subjects with a psychiatric illness, a previous suicide attempt or hospitalization for a psychiatric Dx Will be enrolled at the discretion of the investigator.
  • Concurrent therapy with any immune-modulating agents, e.g,. interleukins, interferons, therapeutic vaccines, corticosteroids, immunosuppressive agents (azathioprine, 6-mercaptopurine, Cyclosporine-A, FK506, Rapamycin, antilymphocyte antibodies).
  • Pregnant or nursing women (all women of child bearing age should be using effective contraception)
  • History of malignancy with receipt of cancer therapy within 24 weeks.
  • Any severe illness that would make the subject unsuitable for the study.
  • Active asthma, or asthma uncontrolled by medication.
  • Any immunologically mediated disease, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, lupus erythematosis, ITP, autoimmune hemolytic anemia, eczema, psoriasis.
  • Untreated thyroid disease.
  • Heroin or cocaine use within 9 months of enrollment.
  • Inadequate venous access.
  • NOTE: If screening TSH is abnormal, obtain free thyroxin index. If the free thyroxine index is normal, the subject may enter the study. If the free thyroxin index is low, the subject may be treated with thyroid hormone replacement medication and enter the study once the free thyroxin index is corrected. If the free thyroxin index is elevated indicating hyperthyroidism, the subject should not enroll in the study.
  • Patients with preexistent antibodies against thyroid peroxidase or thyroglobulin should not be enrolled.
  • Allergy to any of the medications to be used in the study (i.e., IL2, PEG-IFN/RBV), or other components of the study products. Peg Intron: benzyl alcohol, NaCl, Na-phosphate, EDTA, polysorbate 80, m-cresol, IL2; phosphate buffer, SDS, mannitol. RBV: cellulose, lactose, croscarmellose, magnesium stearate, Blue pharmaceutical ink: shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, Blue # 2 aluminum lake.
  • Alcohol dependency, for example, current alcohol use of more than 1 drink/day any time during the previous 6 months. One drink is defined as 12 ounces of beer, 5 ounces of wine, or 1-¼ ounces of hard liquor.
  • Severe retinopathy due to diabetes, hypertension, CMV, or macular degeneration
  • Acute therapy for a serious infection or other serious medical illness that is potentially life threatening and requires systemic therapy and/or hospitalization within 14 days of study entry.
  • Serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min as estimated by the Cockcroft-Gault equation. This screening value must be obtained within 30 days of enrollment.
  • History of major organ transplantation with an existing graft.
  • Subject judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
  • Subjects with biopsy proven liver disease other than HCV infection.
  • Subjects with hemoglobinopathies or any other causes or tendencies toward hemolysis.
  • Subjects with chronic pulmonary disease with functional limitations.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Medical College of Cornell University

    New York, New York, 10021

Other trials in United States

About this study

Official title: A Phase I Study of Low Dose Interleukin 2 (IL-2)Monotherapy, Followed by IL-2 Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I Infection

This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.

Read the detailed description

This is a single center study of 12 weeks of IL-2 lead in immunotherapy followed by 48 weeks of IL2 immunotherapy in combination with Pegylated Interferon Alpha (PEG-IFN-alpha) /Ribavirin (RBV) antiviral therapy for the treatment of individuals infected with Hepatitis C virus (HCV) genotype I. The study is designed to determine whether immunotherapy immunotherapy with low dose daily IL-2 can be safely added to the standard antiviral therapy of 48 weeks of PEG-IFN and RBV. Because IL-2 targets recently antigen- activated T cells, IL-2 therapy will be initiated 12 weeks before PEG-IFN/RBV therapy, when HCV antigen load is high, to activate and expand HCV antigen-specific T cells prior to the initiation of antiviral therapy.

Conditions
Hepatitis C
Being tested
Interleukin 2, Ribavirin, Pegylated Interferon Alpha, Inteleukin-2, Ribavirin + Pegylated interferon-alpha
Keywords
Interleukin-2
Medical subject headings
Hepatitis C

What participants receive

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

  • Interleukin 2Biological

    Also called Proleukin

    Interleukin-2 at 1.2 mU/M2 administered subcutaneously daily

  • RibavirinDrug

    Also called Rebetrol

    Ribavirin @ 800 mg daily (< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (> 85 kg)

  • Pegylated Interferon AlphaBiological

    Also called PEG-Intron

    Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.

  • Inteleukin-2Biological

    Also called Ribavirin, Interferon-alpha

    Interleukin-2 administered as a daily subcutaneous injection at 1.2 mU/M2 BSA

  • Ribavirin + Pegylated interferon-alphaDrug

    Also called PEG-Intron, Rebetrol

    Pegylated interferon-alpha administered 1.5 ug/kg weekly. Ribivirin 800 mg daily for body weight <65 kg, 1000 mg for body weight 65-85 kg, and 1200 mg for body weight >85 kg.

Study groups in NCT00277758
Study groupRoleWhat they receive
1ExperimentalInterventions: 12 weeks of interleukin-2 administration, followed by 48 weeks of interleukin-2 + Ribavirin + interferon-alpha therapy, followed by 24 weeks off therapy
Receives: Biological: Interleukin 2; Drug: Ribavirin; Biological: Pegylated Interferon Alpha; Biological: Inteleukin-2
2Active comparator48 weeks of therapy with Ribavirin + interferon-alpha, followed by 24 weeks off therapy
Receives: Drug: Ribavirin; Biological: Pegylated Interferon Alpha; Drug: Ribavirin + Pegylated interferon-alpha

What is being measured

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

  1. Determination of the safety and tolerability of 12 weeks IL2 monotherapy followed by 48 weeks of IL2 combined with PEG-IFN/RBV

    Measured: 60 weeks of therapy followed by 24 weeks off therapy

Secondary outcomes (1)

  1. Determination of specific immunologic responses to HCV. Immunologic assessment will be performed as the sme time intervals as the assays for plasma virus.

    Measured: 60 weeks of therapy followed by 24 weeks off therapy

Timeline

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

  1. First posted16 Jan 2006 (estimated)
  2. Study startMar 2004
  3. Primary completionJul 2006
  4. Study completionAug 2006

Why it stopped: Insufficient rate of volunteer accrual.

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277758
Sponsor's protocol ID
00-092
Other IDs
U01AI048224
Status last verified
Mar 2008
First submitted
12 Jan 2006
Last updated
7 Mar 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Interleukin 2, Ribavirin and Pegylated Interferon Alpha in people with Hepatitis C, run by Weill Medical College of Cornell University 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 14 inclusion and 29 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: stopped early, as of the sponsor's last update on 7 Mar 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Insufficient rate of volunteer accrual.). Results are not available in the source record.

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?

Determination of the safety and tolerability of 12 weeks IL2 monotherapy followed by 48 weeks of IL2 combined with PEG-IFN/RBV (time frame: 60 weeks of therapy followed by 24 weeks off therapy). 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 NCT00277758.

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 7 Mar 2008.

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