Hepatitis CPhase 1NCT00300807
Study of XTL6865 in Patients With Chronic Hepatitis C Virus Infection
A Phase 1 study testing XTL 6865 in people with Hepatitis C, run by XTL Biopharmaceuticals at 5 sites in 2 countries.
Trial summary
1. Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection. 2. 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?
- XTL 6865
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2005to Apr 2007
- 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
- male or female patients between 18 and 65 years of age;
- female patients must be either postmenopausal, surgically sterile, or non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the study. Female patients of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control during the entire duration of the study. Male patients may be either surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during screening, the treatment period and for 6 weeks following the XTL6865 dose;
- patient has been persistently HCV RNA-positive and remains HCV RNA-positive at screening (patient must have HCV RNA-concentrations which are at least 2 logs above the assay cut-off of 600 IU/mL) and HCV antibody (anti-HCV) positive;
- patient is negative for human immunodeficiency virus (HIV), hepatitis delta virus (HDV), and has no evidence of chronic hepatitis B virus (HBV) infection (assessed by Hepatitis B surface antigen or HBV DNA in blood within 3 months of Day 1 of the study) or other clinical signs, symptoms, or laboratory abnormalities (e.g. amino transferases) leading to the a diagnosis of current acute Hepatitis B disease;
- patient is in reasonably good health, as determined by the Investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests, except for findings related to their hepatitis C positive status.
- subject's private physician has been informed of the subject's planned participation in the study;
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- capable of understanding and complying with the protocol, willing to reside in the study unit during the study period and to cooperate fully with the Investigator and site personnel, and must have signed the informed consent document prior to performance of any study-related procedures;
- infected with HCV genotype 1
- failed previous treatment for HCV infection with an approved regimen of IFN/RBV or pegylated IFN/RBV. Treatment failure includes both non-response (defined as a patient who did not experience a > 2 log decrease in HCV RNA after 12 weeks of treatment or who failed to clear virus to below the limits of detection after 24 weeks of treatment) or relapse (defined as re-emergence of detectable concentrations of HCV RNA after response to treatment). Treatment must have been discontinued at least 3 months prior to Day 1 of the study.
Who cannot join
- liver transplant patients;
- patients with diabetes and HbA1c at screening of 7% or more;
- patients who have previously received HCV-AbXTL68;
- women who are pregnant, lactating, or have a positive serum pregnancy test at screening or positive urine pregnancy test on Day 1 at check-in;
- patient has hemoglobin < 11 g/dL for women and 12 g/dL for men, platelet count < 50,000 cells/mm3, bilirubin > 3 mg/dL, serum creatinine > 1.5 x normal, INR >1.5 x normal, ALT > 5 x upper limit of normal, or serum albumin < 3.0 g/dL (at screening);
- patient has a history or evidence of advanced or decompensated liver disease, ascites, encephalopathy, bleeding esophageal varices, hematuria or proteinuria, alcohol or intravenous drug abuse (within <= 1 years), fulminant liver failure, acute hepatitis from any source, periarteritis nodosa, serum sickness, an acute infectious illness, severe psychiatric disorder (including major depression), organic brain disorder, mental retardation, or other clinical conditions or diseases which in the judgment of the Investigator would interfere with the study or confound the results;
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- patient has present active malignancy (except for superficial cancers)
- past history of pulmonary embolus, deep vein thrombosis, or current therapy with heparin or warfarin;
- patient has a history of pulmonary hypertension;
- patient with hypertension that is not, in the investigator's opinion, adequately controlled by medication (DBP > 90 and SBP > 140). In order to assess PK in the fasted state, patients should be able to delay administration of prescribed anti-hypertensive medicine for several hours without anticipating undue risk of medically significant increases in blood pressure. Patient should be on a stable anti-hypertensive regime for at least 30 days prior to screening with no changes in anti-hypertensive medications.
- patient is currently receiving antiviral therapy for HCV;
- patient has received IFN/RBV or pegylated IFN/RBV treatment within 3 months of study entry (Day 1);
- immunomodulatory therapy (eg, systemic corticosteroids or interferon) within 3 months of study entry (Day 1);
- any patient who does not meet the conditions for prior and concomitant treatments described in Section 6.6 of this protocol;
- any patient considering or scheduled to undergo any surgical procedure during the study;
- has taken any other investigational drug during the 30 days prior to screening visit;
- has donated or lost more than a unit of blood within 30 days prior to screening visit;
- has any condition(s) that in the Investigator's opinion would: a) warrant exclusion from the study or b) prevent the patient from completing the study;
- has limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University Of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Metropolitan Research
Fairfax, Virginia, 22031
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Mt Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase I, Randomized, Double Blind, Placebo-Controlled, Multi-Center Study of the Safety and Virologic Effects of Ascending Single (and Multiple) Doses of XTL6865 in Patients With Chronic Hepatitis C Virus Infection
- Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.
- Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, and virologic activity of escalating single and multiple doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.
An additional purpose of this study is to assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.
This study is a randomized, double blind, placebo-controlled, multi-center design of ascending single doses in patients with chronic hepatitis C virus (HCV) infection. In addition to Placebo, the following XTL6865 doses will be administered: 5 mg, 20 mg, 75 mg, 250 mg, 600 mg, 1200 mg, and 2400 mg. No patient will be enrolled in more than one dose level. At each dose level, 3 patients will receive XTL6865 and 1 patient will receive the Placebo. After the single dose infusion, the patients will be followed for 6 weeks.
If certain criteria are met and the safety review of the 1200 mg dose cohort data determines that XTL6865 was safely administered and tolerated at that dose level, the patients in the 600 mg and 1200 mg dose levels are eligible for the multiple dosing phase. Infusions of 600 mgs will be given to 4 eligible patients, one infusion per day, for 5 days. One patient will receive Placebo and 3 patients will receive XTL6865 600 mg. The patients will be followed for 6 additional weeks.
If certain criteria are not met, the 2400 mg dose cohort will be infused. After the safety review has determined that XTL6865 was safely administered and tolerated, the patients in the 1200 mg and 2400 mg dose levels are eligible for the multiple dosing phase. Infusions of 1200 mgs will be given to 4 eligible patients, one infusion per day, for 5 days. One patients will receive Placebo and 3 patients will receive XTL6865 1200 mg. The patients will be followed for 6 additional weeks.
- Conditions
- Hepatitis C
- Being tested
- XTL 6865
- Keywords
- Hepatitis C, Monoclonal Antibody, failed IFN/RBV treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTL 6865Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
log change in serum concentrations of HCV RNA
change in serum anti-E2 concentrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startOct 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- XTL Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Andrews, PhD, Study director, XTL Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300807
- Sponsor's protocol ID
- XTL2005-16
- Other IDs
- XTL6865
- Status last verified
- Mar 2007
- First submitted
- 7 Mar 2006
- Last updated
- 7 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double Blind, Placebo-Controlled, Multi-Center Study of the Safety and Virologic Effects of Ascending Single (and Multiple) Doses of XTL6865 in Patients With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00300807
- Acronym / sponsor ID
- XTL2005-16
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Monoclonal Antibody, failed IFN/RBV treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants
- Lead sponsor
- XTL BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Apr 2007
- First posted
- 9 Mar 2006 (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.
- Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.
- Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, and virologic activity of escalating single and multiple doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.
An additional purpose of this study is to assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.
This study is a randomized, double blind, placebo-controlled, multi-center design of ascending single doses in patients with chronic hepatitis C virus (HCV) infection. In addition to Placebo, the following XTL6865 doses will be administered: 5 mg, 20 mg, 75 mg, 250 mg, 600 mg, 1200 mg, and 2400 mg. No patient will be enrolled in more than one dose level. At each dose level, 3 patients will receive XTL6865 and 1 patient will receive the Placebo. After the single dose infusion, the patients will be followed for 6 weeks.
If certain criteria are met and the safety review of the 1200 mg dose cohort data determines that XTL6865 was safely administered and tolerated at that dose level, the patients in the 600 mg and 1200 mg dose levels are eligible for the multiple dosing phase. Infusions of 600 mgs will be given to 4 eligible patients, one infusion per day, for 5 days. One patient will receive Placebo and 3 patients will receive XTL6865 600 mg. The patients will be followed for 6 additional weeks.
If certain criteria are not met, the 2400 mg dose cohort will be infused. After the safety review has determined that XTL6865 was safely administered and tolerated, the patients in the 1200 mg and 2400 mg dose levels are eligible for the multiple dosing phase. Infusions of 1200 mgs will be given to 4 eligible patients, one infusion per day, for 5 days. One patients will receive Placebo and 3 patients will receive XTL6865 1200 mg. The patients will be followed for 6 additional weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female patients between 18 and 65 years of age;
- female patients must be either postmenopausal, surgically sterile, or non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the study. Female patients of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control during the entire duration of the study. Male patients may be either surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during screening, the treatment period and for 6 weeks following the XTL6865 dose;
- patient has been persistently HCV RNA-positive and remains HCV RNA-positive at screening (patient must have HCV RNA-concentrations which are at least 2 logs above the assay cut-off of 600 IU/mL) and HCV antibody (anti-HCV) positive;
- patient is negative for human immunodeficiency virus (HIV), hepatitis delta virus (HDV), and has no evidence of chronic hepatitis B virus (HBV) infection (assessed by Hepatitis B surface antigen or HBV DNA in blood within 3 months of Day 1 of the study) or other clinical signs, symptoms, or laboratory abnormalities (e.g. amino transferases) leading to the a diagnosis of current acute Hepatitis B disease;
- patient is in reasonably good health, as determined by the Investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests, except for findings related to their hepatitis C positive status.
Key exclusion criteria (19 listed)
- liver transplant patients;
- patients with diabetes and HbA1c at screening of 7% or more;
- patients who have previously received HCV-AbXTL68;
- women who are pregnant, lactating, or have a positive serum pregnancy test at screening or positive urine pregnancy test on Day 1 at check-in;
- patient has hemoglobin < 11 g/dL for women and 12 g/dL for men, platelet count < 50,000 cells/mm3, bilirubin > 3 mg/dL, serum creatinine > 1.5 x normal, INR >1.5 x normal, ALT > 5 x upper limit of normal, or serum albumin < 3.0 g/dL (at screening);
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 |
|---|---|---|
| XTL 6865 | Drug | – |
Primary outcome
log change in serum concentrations of HCV RNA
change in serum anti-E2 concentrations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2007.
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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.
John Andrews, PhD study director
XTL Biopharmaceuticals
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XTL 6865 in people with Hepatitis C, run by XTL Biopharmaceuticals at 5 sites in 2 countries.
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 9 inclusion and 19 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 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Israel. 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?
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?
log change in serum concentrations of HCV RNA. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2007.