LeishmaniasisPhase 1/2NCT01437020
SCH708980 With and Without AmBisome for Visceral Leishmaniasis
A Phase 1/2 study testing SCH708980 Anti-IL-10 monoclonal and AmBisome in people with Leishmaniasis and Effects of Immunotherapy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in India.
Trial summary
Background: Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leishmaniasis, Effects of Immunotherapy
- What is being tested?
- SCH708980 Anti-IL-10 monoclonal and AmBisome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesIndia
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects (18 to 60 years of age) who meet the following criteria are eligible to enter the study:
- Newly diagnosed VL (within 4 to 5 days of screening) and confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever (> 99 degrees F) over a 2-week duration, splenomegaly (palpable spleen below the costal margin), and weight loss.
- Biochemical and hematological test values:
- Hemoglobin > 6.0g/100mL.
- WBC count > 1.0 times 10(9)/L.
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- Platelet count > 40 times 10(9)/L.
- Aspartate aminotransferase (AST),alanine transaminase (ALT), and alkaline phosphatase < 3 times the upper limit of normal.
- Prothrombin time (PT) < 4 seconds above the control values.
- Serum creatinine levels within normal limits (males, 0.7 mg/dL - 1.1 mg/dL; females, 0.6 mg/dL - 0.9 mg/dL).
- Human immunodeficiency virus (HIV)-negative status.
- Willingness to be hospitalized for 30 days.
- Willingness to have samples stored.
- Negative serum pregnancy test result for women of childbearing potential.
Who cannot join
- A history of intercurrent or concurrent diseases (e.g., chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular, or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which, in the investigator's opinion, may prevent the subject from completing the study and the subsequent follow-up.
- Previous treatment for VL within 45 days of study enrollment.
- A history of allergy or hypersensitivity to amphotericin B.
- Prior treatment failures with amphotericin B.
- Current use of other drugs with known anti-leishmanial activity (e.g., antimonials, pentamidine, paromomycin, miltefosine), azoles (e.g., fluconazole, ketoconazole or itraconazole), nephrotoxic drugs, immunosuppressive drugs, other investigational agents, immunomodulatory drugs.
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- Breastfeeding women
- Vaccinations within 30 days prior to enrollment in the study.
- Subjects younger than 18 years of age will be excluded from the study because insufficient data are available supporting dosing with SCH708980 in adults to judge the potential risk in children.
- Pregnant and lactating women are excluded from the study because insufficient data are available supporting dosing with SCH708980 in these populations to judge the potential risk.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Kala-Azar Medical Research Center (KAMRC), Rambag Road
Muzaffarpur
Banaras Hindu University
Varanasi
About this study
Official title: A Phase I/II Clinical Trial To Assess the Safety and Biologic Activity of the Anti-IL-10 Monoclonal Antibody, SCH708980, in Combination With AmBisome(Registered Trademark), Versus That of Placebo in Combination With Ambisome(Registered Trademark), in Subjects With Visceral Leishmaniasis (VL)
Background:
- Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system. One possible treatment for VL involves an experimental drug called SCH708980, which may help to prevent the immune system from becoming suppressed and worsening the VL. Researchers want to give the drug along with AmBisome(Registered Trademark), which kills the parasites, to see if it is a safe and effective treatment.
Read more
Objectives:
- To study the safety and effectiveness of SCH708980, alone and combined with AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.
Eligibility:
- Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days.
- All participants will come from and be treated at the Kala-Azar Medical Research Center in Muzaffarpur, India.
Design:
- This is a two-part study. Participants will be assigned to only one part of the study.
- Participants will be screened with a medical history and physical exam; blood, urine, and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and a heart function test.
- Part 1 participants will be separated into two groups: a larger group will have a selected dose of the study drug followed by AmBisome 7 days later, and a smaller group will have a placebo treatment followed by AmBisome.
- Part 2 participants will have either the study drug or a placebo plus AmBisome, based on the test results from the Part 1 participants.
- All participants will be monitored in the hospital for 30 days, and will have the following tests:
- Regular blood samples
- Urine and stool samples (day 14)
- Spleen measurements (days 8, 14, 21, and 30)
- Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will give another sample on day 45.
- At 6 months after the start of treatment, participants will have a follow-up visit with spleen measurements, blood and stool samples, and possible spleen or bone marrow samples
Read the detailed description
Visceral leishmaniasis (VL) or kala-azar is the most severe form of leishmaniasis, which can be fatal if left untreated. The majority of VL cases are found in resource-poor regions, including India (Bihar), Bangladesh, Brazil, Nepal, and Sudan. VL pathogenesis has been linked to an overproduction of the anti-inflammatory cytokine, interleukin (IL)-10, which can promote parasite replication and disease progression. Experimental models have shown that IL-10 plays a key role in the pathogenesis of VL.
The current study has two parts. Part 1 will be an open-label, dose-escalating design to determine the safety and tolerability of SCH708980 used in combination with AmBisome(Registered Trademark). Part 2 will be a randomized, single-blind, placebo-controlled, parallel design. A total of 50 subjects (n=10 subjects/group) will be enrolled in part 1 of the study. A group of 10 subjects will be observed for 7 days prior to receiving AmBisome(Registered Trademark) (10 mg/kg) on the 8th day, as part of the control group. Subsequently, 40 subjects (10 subjects/group) will receive a single intravenous (IV) infusion of SCH708980 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10 mg/kg) followed by a single IV infusion of AmBisome(Registered Trademark) (10 mg/kg) 7 days later. The first 2 subjects from each dose group to receive SCH708980 will be followed for 3 days after the drug is administered before treatment is initiated in the remaining 8 subjects in that group. Also, all individuals in each group will be followed for 7 days after AmBisome(Registered Trademark) is administered before the next higher dose-level group is enrolled in the study. Dose escalation will continue to the next dose level unless dose-limiting toxicities occur in > 20% of subjects in any cohort.
The dose level of SCH708980 to use in part 2 of the study will be decided 30 days after the start of AmBisome(Registered Trademark) treatment in the group receiving the highest dose in part 1. Randomization and accrual for part 2 of the study will begin at this time. The highest safe dose of SCH709890 (< 20% of subjects with dose-limiting toxicity) will be administered to subjects, not to exceed 10 mg/kg. Thirty subjects (n=10 subjects/group) will be randomized to 1:1:1 to receive:
- A single IV infusion of SCH708980 (less than or equal to 10.0 mg/kg) on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (3.75 mg/kg) on day 8.
- A single IV infusion of SCH708980 (less than or equal to 10.0 mg/kg) on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (5 mg/kg) on day 8.
- A single dose of placebo on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (10 mg/kg) on day 8.
SCH709890 and placebo will be administered over 60 minutes, while AmBisome(Registered Trademark) will be administered over 120 minutes.
- Conditions
- Leishmaniasis, Effects of Immunotherapy
- Being tested
- SCH708980 Anti-IL-10 monoclonal, AmBisome
- Keywords
- IL-10, Leishmaniasis, Immunotherapy
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH708980 Anti-IL-10 monoclonalDrug
Participants in Part 1 of the study will receive varying doses (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10.0 mg/kg) of a single IV infusion of SCH708980. Participants in Part 2 of the study will receive a single IV infusion of SCH708980 on Day 1.
AmBisomeDrug
Participants in Part 1 of the study will receive a single IV infusion of AmBisome (10 mg/kg) 7 days after they receive SCH708980. Participants in Part 2 of the study will receive varying doses (3.75 mg/kg, 5 mg/kg, or 10 mg/kg) of a single IV infusion of AmBisome on Day 8.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalating-IV infusion of SCH708980 and Ambisome | Experimental | Not described Receives: Drug: SCH708980 Anti-IL-10 monoclonal; Drug: AmBisome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of a single IV infusion of SCH708980 (0.3 mg/kg, 1.0 mg/kg, 3 mg/kg, or 10 mg/kg) over the initial 7 days and in combination with a single IV infusion of AmBisome® (10 mg/kg) on the 8th day in part 1 of the study
Measured: Measured through Day 8
Secondary outcomes (4)
The anti-IL-10 parasitic effect, as measured by real-time polymerase chain reaction (RT-PCR)
Measured: Measured 6 months after the start of treatment
Serum concentrations of SCH708980
Measured: Measured 6 months after the start of treatment
Clinical response
Measured: Measured 6 months after the start of treatment
Outcomes at 6 months post-treatment
Measured: Measured 6 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
Why it stopped: Drug Product no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeishmaniasisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shyam Sundar, MD, Principal investigator, Institute of Medical Sciences, Banaras Hindu Universtiy, Varanasi, IndiaDavid Sacks, PhD, Principal investigator, Laboratory of Parasitic Diseases, NIAID, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437020
- Sponsor's protocol ID
- 11-I-N222
- Other IDs
- 11-I-N222
- Status last verified
- Aug 2013
- First submitted
- 16 Sep 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desjeux P. Leishmaniasis. Public health aspects and control. Clin Dermatol. 1996 Sep-Oct;14(5):417-23. doi: 10.1016/0738-081x(96)00057-0. No abstract available.
PubMed 8889319Addy M, Nandy A. Ten years of kala-azar in west Bengal, Part I. Did post-kala-azar dermal leishmaniasis initiate the outbreak in 24-Parganas? Bull World Health Organ. 1992;70(3):341-6.
PubMed 1638662Bern C, Hightower AW, Chowdhury R, Ali M, Amann J, Wagatsuma Y, Haque R, Kurkjian K, Vaz LE, Begum M, Akter T, Cetre-Sossah CB, Ahluwalia IB, Dotson E, Secor WE, Breiman RF, Maguire JH. Risk factors for kala-azar in Bangladesh. Emerg Infect Dis. 2005 May;11(5):655-62. doi: 10.3201/eid1105.040718.
PubMed 15890115
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial To Assess the Safety and Biologic Activity of the Anti-IL-10 Monoclonal Antibody, SCH708980, in Combination With AmBisome(Registered Trademark), Versus That of Placebo in Combination With Ambisome(Registered Trademark), in Subjects With Visceral Leishmaniasis (VL)
- ClinicalTrials.gov ID
- NCT01437020
- Acronym / sponsor ID
- 11-I-N222
- Conditions
- Leishmaniasis, Effects of Immunotherapy
- Keywords
- IL-10, Leishmaniasis, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug Product no longer available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 20 Sep 2011 (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.
Background:
- Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system. One possible treatment for VL involves an experimental drug called SCH708980, which may help to prevent the immune system from becoming suppressed and worsening the VL. Researchers want to give the drug along with AmBisome(Registered Trademark), which kills the parasites, to see if it is a safe and effective treatment.
Objectives:
- To study the safety and effectiveness of SCH708980, alone and combined with AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.
Eligibility:
- Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days.
- All participants will come from and be treated at the Kala-Azar Medical Research Center in Muzaffarpur, India.
Design:
- This is a two-part study. Participants will be assigned to only one part of the study.
- Participants will be screened with a medical history and physical exam; blood, urine, and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and a heart function test.
- Part 1 participants will be separated into two groups: a larger group will have a selected dose of the study drug followed by AmBisome 7 days later, and a smaller group will have a placebo treatment followed by AmBisome.
- Part 2 participants will have either the study drug or a placebo plus AmBisome, based on the test results from the Part 1 participants.
- All participants will be monitored in the hospital for 30 days, and will have the following tests:
- Regular blood samples
- Urine and stool samples (day 14)
- Spleen measurements (days 8, 14, 21, and 30)
- Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will give another sample on day 45.
- At 6 months after the start of treatment, participants will have a follow-up visit with spleen measurements, blood and stool samples, and possible spleen or bone marrow samples
Detailed description
Visceral leishmaniasis (VL) or kala-azar is the most severe form of leishmaniasis, which can be fatal if left untreated. The majority of VL cases are found in resource-poor regions, including India (Bihar), Bangladesh, Brazil, Nepal, and Sudan. VL pathogenesis has been linked to an overproduction of the anti-inflammatory cytokine, interleukin (IL)-10, which can promote parasite replication and disease progression. Experimental models have shown that IL-10 plays a key role in the pathogenesis of VL.
The current study has two parts. Part 1 will be an open-label, dose-escalating design to determine the safety and tolerability of SCH708980 used in combination with AmBisome(Registered Trademark). Part 2 will be a randomized, single-blind, placebo-controlled, parallel design. A total of 50 subjects (n=10 subjects/group) will be enrolled in part 1 of the study. A group of 10 subjects will be observed for 7 days prior to receiving AmBisome(Registered Trademark) (10 mg/kg) on the 8th day, as part of the control group. Subsequently, 40 subjects (10 subjects/group) will receive a single intravenous (IV) infusion of SCH708980 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10 mg/kg) followed by a single IV infusion of AmBisome(Registered Trademark) (10 mg/kg) 7 days later. The first 2 subjects from each dose group to receive SCH708980 will be followed for 3 days after the drug is administered before treatment is initiated in the remaining 8 subjects in that group. Also, all individuals in each group will be followed for 7 days after AmBisome(Registered Trademark) is administered before the next higher dose-level group is enrolled in the study. Dose escalation will continue to the next dose level unless dose-limiting toxicities occur in > 20% of subjects in any cohort.
The dose level of SCH708980 to use in part 2 of the study will be decided 30 days after the start of AmBisome(Registered Trademark) treatment in the group receiving the highest dose in part 1. Randomization and accrual for part 2 of the study will begin at this time. The highest safe dose of SCH709890 (< 20% of subjects with dose-limiting toxicity) will be administered to subjects, not to exceed 10 mg/kg. Thirty subjects (n=10 subjects/group) will be randomized to 1:1:1 to receive:
- A single IV infusion of SCH708980 (less than or equal to 10.0 mg/kg) on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (3.75 mg/kg) on day 8.
- A single IV infusion of SCH708980 (less than or equal to 10.0 mg/kg) on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (5 mg/kg) on day 8.
- A single dose of placebo on day 1 followed by a single IV infusion of AmBisome(Registered Trademark) (10 mg/kg) on day 8.
SCH709890 and placebo will be administered over 60 minutes, while AmBisome(Registered Trademark) will be administered over 120 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalating-IV infusion of SCH708980 and Ambisome | Experimental | Drug: SCH708980 Anti-IL-10 monoclonal, Drug: AmBisome |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subjects (18 to 60 years of age) who meet the following criteria are eligible to enter the study:
- Newly diagnosed VL (within 4 to 5 days of screening) and confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever (> 99 degrees F) over a 2-week duration, splenomegaly (palpable spleen below the costal margin), and weight loss.
- Biochemical and hematological test values:
- Hemoglobin > 6.0g/100mL.
Key exclusion criteria (10 listed)
- A history of intercurrent or concurrent diseases (e.g., chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular, or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which, in the investigator's opinion, may prevent the subject from completing the study and the subsequent follow-up.
- Previous treatment for VL within 45 days of study enrollment.
- A history of allergy or hypersensitivity to amphotericin B.
- Prior treatment failures with amphotericin B.
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 |
|---|---|---|
| SCH708980 Anti-IL-10 monoclonalParticipants in Part 1 of the study will receive varying doses (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10.0 mg/kg) of a single IV infusion of SCH708980. Participants in Part 2 of the study will receive a single IV infusion of SCH708980 on Day 1. | Drug | Dose escalating-IV infusion of SCH708980 and Ambisome |
| AmBisomeParticipants in Part 1 of the study will receive a single IV infusion of AmBisome (10 mg/kg) 7 days after they receive SCH708980. Participants in Part 2 of the study will receive varying doses (3.75 mg/kg, 5 mg/kg, or 10 mg/kg) of a single IV infusion of AmBisome on Day 8. | Drug | Dose escalating-IV infusion of SCH708980 and Ambisome |
Primary outcome
Evaluate the safety and tolerability of a single IV infusion of SCH708980 (0.3 mg/kg, 1.0 mg/kg, 3 mg/kg, or 10 mg/kg) over the initial 7 days and in combination with a single IV infusion of AmBisome® (10 mg/kg) on the 8th day in part 1 of the study
Time frame: Measured through Day 8
4 secondary outcomes
The anti-IL-10 parasitic effect, as measured by real-time polymerase chain reaction (RT-PCR)
Time frame: Measured 6 months after the start of treatment
Serum concentrations of SCH708980
Time frame: Measured 6 months after the start of treatment
Clinical response
Time frame: Measured 6 months after the start of treatment
Outcomes at 6 months post-treatment
Time frame: Measured 6 months after the start of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Background: PubMed 8889319Desjeux P. Leishmaniasis. Public health aspects and control. Clin Dermatol. 1996 Sep-Oct;14(5):417-23. doi: 10.1016/0738-081x(96)00057-0. No abstract available.
- Background: PubMed 1638662Addy M, Nandy A. Ten years of kala-azar in west Bengal, Part I. Did post-kala-azar dermal leishmaniasis initiate the outbreak in 24-Parganas? Bull World Health Organ. 1992;70(3):341-6.
- Background: PubMed 15890115Bern C, Hightower AW, Chowdhury R, Ali M, Amann J, Wagatsuma Y, Haque R, Kurkjian K, Vaz LE, Begum M, Akter T, Cetre-Sossah CB, Ahluwalia IB, Dotson E, Secor WE, Breiman RF, Maguire JH. Risk factors for kala-azar in Bangladesh. Emerg Infect Dis. 2005 May;11(5):655-62. doi: 10.3201/eid1105.040718.
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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.
Shyam Sundar, MD principal investigator
Institute of Medical Sciences, Banaras Hindu Universtiy, Varanasi, India
David Sacks, PhD principal investigator
Laboratory of Parasitic Diseases, NIAID, NIH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCH708980 Anti-IL-10 monoclonal and AmBisome in people with Leishmaniasis and Effects of Immunotherapy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in India.
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 10 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: withdrawn, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the safety and tolerability of a single IV infusion of SCH708980 (0.3 mg/kg, 1.0 mg/kg, 3 mg/kg, or 10 mg/kg) over the initial 7 days and in combination with a single IV infusion of AmBisome® (10 mg/kg) on the 8th day in part 1 of the study (time frame: Measured through Day 8). 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 NCT01437020, which also lists 3 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 28 Aug 2013.