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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 3, 2011 | ||||||||
| Last Updated Date | May 9, 2012 | ||||||||
| Start Date ICMJE | May 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence and severity of adverse events [ Time Frame: Weekly assessment over 24 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01371305 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | ||||||||
| Official Title ICMJE | Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | ||||||||
| Brief Summary | This is a multi-center, randomized, double-blind, placebo-controlled, multiple dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact on BAL and peripheral blood biomarkers of STX-100 in patients with IPF. Approximately 32 patients will be enrolled into 4 sequential ascending dose cohorts. Each cohort will include 8 patients randomized to receive either STX-100 (6 patients) or placebo (2 patients). Additional patients may be enrolled if deemed appropriate by the Data Safety Monitoring Board (DSMB). |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Idiopathic Pulmonary Fibrosis (IPF) | ||||||||
| Intervention ICMJE |
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| Study Arms |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 84 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01371305 | ||||||||
| Other Study ID Numbers ICMJE | STX-003 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | ( Stromedix, Inc. ) | ||||||||
| Study Sponsor ICMJE | Stromedix, Inc. | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Stromedix, Inc. | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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