Hepatitis CPhase 1NCT01165359
Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults
A Phase 1 study testing ITX 5061 in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in 2 countries.
Trial summary
Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood. 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?
- ITX 5061
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2010to Mar 2012
- 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
- Absence of HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 45 days prior to study entry
- Chronic HCV infection as defined and documented by testing. See protocol for details.
- HCV genotype 1 infection with source documentation from a College of American Pathologists (CAP) or Clinical Laboratory Improvement Amendments (CLIA) approved laboratory (or its equivalent) within 1 year prior to study entry. Those without a documented genotype result at screening will have a screening genotype performed either locally or provided by the study as described in the protocol.
- Serum or plasma HCV RNA greater than or equal to 100,000 IU/mL (5 log10) obtained within 45 days prior to study entry by any laboratory that has a CLIA certification or its equivalent
- Lack of significant hepatic fibrosis (bridging fibrosis or cirrhosis) confirmed by biopsy within 2 years of study entry or HCV FibroSURE score of less than or equal to METAVIR stage 2 within 1 year of study entry
- The following laboratory values obtained within 45 days prior to study entry:
Show all 20Show fewer
- White blood cell (WBC) count greater than or equal to 3000/mm3
- Absolute neutrophil count (ANC) greater than or equal to 1000/mm3
- Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 11 g/dL for women
- Platelet count greater than or equal to 120,000/mm3
- Alanine aminotransferase (ALT) less than or equal to 5 x the upper limit of normal (ULN)
- International normalized ratio (INR) less than 1.5
- Total bilirubin less than or equal to ULN
- Calculated creatinine clearance (CrCl) greater than or equal to 80 mL/min, as estimated by the Cockcroft-Gault equation. More information on this criterion can be found in the protocol.
- Hemoglobin A1c (HbA1c) less than or equal to 8.5% for participants with diabetes; must be obtained within 90 days prior to study entry
- Females of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mlU/mL within 45 days prior to study entry. More information on this criterion can be found in the protocol.
- All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization)
- If participating in sexual activity that could lead to pregnancy, participants must agree to use two reliable methods of contraception simultaneously while receiving study treatment and for 6 weeks after stopping study treatment. More information on this criterion can be found in the protocol.
- Participants who are not of reproductive potential are eligible to participate without requiring the use of contraceptives, with acceptable documentation of either sterilization or menopause required. More information on this criterion can be found in the protocol.
- Able and willing to provide written informed consent
Who cannot join
- Prior receipt of any interferon or ribavirin (RBV)
- Prior receipt of any therapy for HCV, including experimental treatments
- Evidence of decompensated liver disease manifested by presence of or history of ascites, variceal bleeding, or hepatic encephalopathy
- History of Gilbert's syndrome
- Presence of other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency
- History of known hepatocellular carcinoma
Show all 15Show fewer
- History of major organ transplantation with an existing functional graft
- History of uncontrolled seizure disorders
- Breastfeeding
- Use of prohibited medications within 14 days prior to study entry. More information on this criterion can be found in the protocol.
- Initiation or change in dose of any nonprohibited prescription medication within 14 days prior to study entry
- Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation
- Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization within 24 weeks prior to study entry; serious illness including malignancy, active coronary artery disease within 24 weeks prior to study entry; other chronic medical conditions that may preclude completion of the study in the clinical research site (CRS) investigator's opinion. Such conditions may be discussed with the protocol chair/vice chair (actgcorea5277@fstrf.org).
- Participation in a prior A5277 cohort
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland
Alabama Therapeutics CRS
Birmingham, Alabama, 35294-2050
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267-0405
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
UCLA CARE Center CRS
Los Angeles, California, 90035
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California, 94110
About this study
Official title: A Randomized, Double-Blind, Phase 1b Study to Assess the Safety and Activity of the HCV Entry Inhibitor ITX 5061 in Treatment-Naive HCV Mono-Infected Adults
Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood.
Read the detailed description
HCV is a serious health concern and can lead to cirrhosis, liver cancer, and liver failure. Currently, HCV is treated with pegylated interferon and ribavirin, but these medications are not always effective and may have harmful side effects. ITX 5061 is a new medication that has been developed to treat HCV. This study will take place in three parts-Parts A, B, and C. Each part of the study will enroll participants for a different period of time, and within each part of the study, participants will receive varying amounts of ITX 5061. If ITX 5061 is found to be unsafe in any part of the study, the subsequent parts of the study will not occur. The purpose of this study is to evaluate the safety of different doses of ITX 5061 and determine the amount of time that is needed for ITX 5061 to safely lower the amount of HCV in the blood.
This study will enroll people with HCV who are HIV-uninfected. Participants will enroll in one of three parts of the study. They will be randomly assigned to receive ITX 5061 or placebo once a day for 3 days in Part A, for 14 days in Part B, or for 28 days in Part C. Within Parts A, B, and C, participants will receive either 150 mg, 75, mg, or 25 mg of ITX 5061. At a baseline study visit, participants will have a physical exam and blood and urine collection. All participants will receive their assigned medication at this visit. Participants in Part A will return for study visits on the 2 days after the baseline visit. During these study visits, participants will undergo a physical exam and will have blood collected several times over an 8-hour period. Participants in Part B of the study will attend study visits 1, 2, 3, 7, 10, and 13 days after the baseline visit. Participants in Part C of the study will attend study visits 1, 2, 3, 7, 10, 14, 21, and 27 days after the baseline visit. Participants in Parts B and C will undergo similar study procedures as participants in Part A. Throughout the study, participants will record their medication usage in a diary.
All participants will attend a study visit the day after they receive their last medication dose. In addition, participants in Part A will attend study visits 9 and 16 days after the baseline visit, participants in Part B will attend study visits 20 and 27 days after the baseline visit, and participants in Part C will attend study visits 34 and 41 days after the baseline visit. At each of these follow-up visits, participants will have a physical exam and a blood and urine collection.
- Conditions
- Hepatitis C
- Being tested
- ITX 5061, Placebo ITX 5061
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITX 5061Drug
For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days.
For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days.
For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days.
Placebo ITX 5061Drug
For Part A of the study: placebo, once a day for 3 days.
For Part B of the study: placebo, once a day for 14 days.
For Part C of the study: placebo, once a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Part A: ITX 5061 | Experimental | Participants will receive ITX 5061 once a day for 3 days. Receives: Drug: ITX 5061 |
| Part A: Placebo | Placebo comparator | Participants will receive placebo once a day for 3 days. Receives: Drug: Placebo ITX 5061 |
| Part B: ITX 5061 | Experimental | Participants will receive ITX 5061 once a day for 14 days. Receives: Drug: ITX 5061 |
| Part B: Placebo | Placebo comparator | Participants will receive placebo once a day for 14 days. Receives: Drug: Placebo ITX 5061 |
| Part C: ITX 5061 | Experimental | Participants will receive ITX 5061 once a day for 28 days. Receives: Drug: ITX 5061 |
| Part C: Placebo | Placebo comparator | Participants will receive placebo once a day for 28 days. Receives: Drug: Placebo ITX 5061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serum HCV RNA level greater than or equal to 1 log10 IU/mL from baseline at the end of treatment
Measured: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Adverse events (AEs) greater than or equal to grade 3 attributed to the study treatment by the cohort review group
Measured: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Secondary outcomes (3)
Pharmacokinetic parameters (area under the curve [AUC], Cmax, Cmin) for ITX 5061
Measured: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Quantitative change in HCV RNA from baseline at the study visits
Measured: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
All reported AEs
Measured: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionMar 2012
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Sulkowski, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165359
- Sponsor's protocol ID
- A5277
- Other IDs
- 10836
- Status last verified
- Oct 2021
- First submitted
- 15 Jul 2010
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 1b Study to Assess the Safety and Activity of the HCV Entry Inhibitor ITX 5061 in Treatment-Naive HCV Mono-Infected Adults
- ClinicalTrials.gov ID
- NCT01165359
- Acronym / sponsor ID
- A5277
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Jul 2010 (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.
Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood.
Detailed description
HCV is a serious health concern and can lead to cirrhosis, liver cancer, and liver failure. Currently, HCV is treated with pegylated interferon and ribavirin, but these medications are not always effective and may have harmful side effects. ITX 5061 is a new medication that has been developed to treat HCV. This study will take place in three parts-Parts A, B, and C. Each part of the study will enroll participants for a different period of time, and within each part of the study, participants will receive varying amounts of ITX 5061. If ITX 5061 is found to be unsafe in any part of the study, the subsequent parts of the study will not occur. The purpose of this study is to evaluate the safety of different doses of ITX 5061 and determine the amount of time that is needed for ITX 5061 to safely lower the amount of HCV in the blood.
This study will enroll people with HCV who are HIV-uninfected. Participants will enroll in one of three parts of the study. They will be randomly assigned to receive ITX 5061 or placebo once a day for 3 days in Part A, for 14 days in Part B, or for 28 days in Part C. Within Parts A, B, and C, participants will receive either 150 mg, 75, mg, or 25 mg of ITX 5061. At a baseline study visit, participants will have a physical exam and blood and urine collection. All participants will receive their assigned medication at this visit. Participants in Part A will return for study visits on the 2 days after the baseline visit. During these study visits, participants will undergo a physical exam and will have blood collected several times over an 8-hour period. Participants in Part B of the study will attend study visits 1, 2, 3, 7, 10, and 13 days after the baseline visit. Participants in Part C of the study will attend study visits 1, 2, 3, 7, 10, 14, 21, and 27 days after the baseline visit. Participants in Parts B and C will undergo similar study procedures as participants in Part A. Throughout the study, participants will record their medication usage in a diary.
All participants will attend a study visit the day after they receive their last medication dose. In addition, participants in Part A will attend study visits 9 and 16 days after the baseline visit, participants in Part B will attend study visits 20 and 27 days after the baseline visit, and participants in Part C will attend study visits 34 and 41 days after the baseline visit. At each of these follow-up visits, participants will have a physical exam and a blood and urine collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: ITX 5061 | Experimental | Drug: ITX 5061Participants will receive ITX 5061 once a day for 3 days. |
| Part A: Placebo | Placebo comparator | Drug: Placebo ITX 5061Participants will receive placebo once a day for 3 days. |
| Part B: ITX 5061 | Experimental | Drug: ITX 5061Participants will receive ITX 5061 once a day for 14 days. |
| Part B: Placebo | Placebo comparator | Drug: Placebo ITX 5061Participants will receive placebo once a day for 14 days. |
| Part C: ITX 5061 | Experimental | Drug: ITX 5061Participants will receive ITX 5061 once a day for 28 days. |
| Part C: Placebo | Placebo comparator | Drug: Placebo ITX 5061Participants will receive placebo once a day for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Absence of HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 45 days prior to study entry
- Chronic HCV infection as defined and documented by testing. See protocol for details.
- HCV genotype 1 infection with source documentation from a College of American Pathologists (CAP) or Clinical Laboratory Improvement Amendments (CLIA) approved laboratory (or its equivalent) within 1 year prior to study entry. Those without a documented genotype result at screening will have a screening genotype performed either locally or provided by the study as described in the protocol.
- Serum or plasma HCV RNA greater than or equal to 100,000 IU/mL (5 log10) obtained within 45 days prior to study entry by any laboratory that has a CLIA certification or its equivalent
- Lack of significant hepatic fibrosis (bridging fibrosis or cirrhosis) confirmed by biopsy within 2 years of study entry or HCV FibroSURE score of less than or equal to METAVIR stage 2 within 1 year of study entry
Key exclusion criteria (15 listed)
- Prior receipt of any interferon or ribavirin (RBV)
- Prior receipt of any therapy for HCV, including experimental treatments
- Evidence of decompensated liver disease manifested by presence of or history of ascites, variceal bleeding, or hepatic encephalopathy
- History of Gilbert's syndrome
- Presence of other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency
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 |
|---|---|---|
| ITX 5061For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days. For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days. For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days. | Drug | Part A: ITX 5061, Part B: ITX 5061, Part C: ITX 5061 |
| Placebo ITX 5061For Part A of the study: placebo, once a day for 3 days. For Part B of the study: placebo, once a day for 14 days. For Part C of the study: placebo, once a day for 28 days. | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo |
Primary outcome
Reduction in serum HCV RNA level greater than or equal to 1 log10 IU/mL from baseline at the end of treatment
Time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Adverse events (AEs) greater than or equal to grade 3 attributed to the study treatment by the cohort review group
Time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
3 secondary outcomes
Pharmacokinetic parameters (area under the curve [AUC], Cmax, Cmin) for ITX 5061
Time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Quantitative change in HCV RNA from baseline at the study visits
Time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
All reported AEs
Time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Mark Sulkowski, MD study chair
Johns Hopkins University
10 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 ITX 5061 in people with Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 20 inclusion and 15 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 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?
Reduction in serum HCV RNA level greater than or equal to 1 log10 IU/mL from baseline at the end of treatment (time frame: Measured at the end of treatment (Day 3 in Part A, Day 14 in Part B, and Day 28 in Part C)). 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 1 Nov 2021.