Trials / Withdrawn
WithdrawnNCT02533362
ANF-Rho in the Treatment of Chronic Neutropenia
A Phase 2, Open-Label, Single Center, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of ANF-Rho™ in Patients With Chronic Neutropenia
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Prolong Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat patients with chronic neutropenia.
Detailed description
Chronic neutropenia patients who are eligible for participation will be screened and enrolled to received open-label ANF-Rho for a period of 6 months. Study participation will be separated into 2 periods, Induction (8 weeks) and Maintenance (16 weeks). Blood samples to measure neutrophil levels and biochemistry labs will be drawn throughout the study to monitor efficacy response and patient safety. Pharmacokinetic samples will be collected during both periods and questionnaires will be completed by the patient and investigator for bone pain, quality of life (QOL) and injection site reaction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ANF-Rho | Pegylated version of recombinant human granulocyte-colony stimulating factor (G-CSF) |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2015-08-26
- Last updated
- 2019-03-06
Source: ClinicalTrials.gov record NCT02533362. Inclusion in this directory is not an endorsement.