Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment (KB001-A)
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| ClinicalTrials.gov Identifier: NCT01695343 |
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Recruitment Status :
Completed
First Posted : September 27, 2012
Last Update Posted : January 14, 2015
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Sponsor:
Humanigen, Inc.
Information provided by (Responsible Party):
Humanigen, Inc.
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Brief Summary:
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Biological: KB001-A Drug: Placebo Comparator | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 182 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: KB001-A
KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
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Biological: KB001-A |
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Placebo Comparator: Placebo Comparator
Placebo administered up to 5x intravenously
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Drug: Placebo Comparator |
Primary Outcome Measures :
- To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. [ Time Frame: 16 Weeks ]Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.
Secondary Outcome Measures :
- Safety and tolerability of KB001-A [ Time Frame: 16 Weeks ]Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments
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| Ages Eligible for Study: | 12 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit
- Confirmed diagnosis of CF
- At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening)
- FEV1 % levels within acceptable ranges (per the study protocol)
- Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit
Exclusion Criteria:
- Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
- Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
- Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit
- History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit
- History of organ transplantation
- Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited
- History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
- History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction
- Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
- Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695343
Locations
Show 67 study locations
Sponsors and Collaborators
Humanigen, Inc.
Investigators
| Study Chair: | Nestor A. Molfino, MD., MSc | KaloBios Pharmaceuticals, Inc. |
| Responsible Party: | Humanigen, Inc. |
| ClinicalTrials.gov Identifier: | NCT01695343 |
| Other Study ID Numbers: |
KB001A-05 |
| First Posted: | September 27, 2012 Key Record Dates |
| Last Update Posted: | January 14, 2015 |
| Last Verified: | January 2015 |
Keywords provided by Humanigen, Inc.:
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Cystic Fibrosis Pseudomonas aeruginosa (Pa) CF |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |