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NCT01335165 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01335165: Clinical Trial Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT01335165 is a Phase 1 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335165, a Phase 1 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.
Primary Outcome
Safety and tolerability will be evaluated in all subjects by physical exam, vital signs, ECGs, laboratory changes over time, adverse events, and antibody development.
Interventions
- DRUG ALXN1102
- DRUG ALXN1103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
Why NCT01335165 stopped before completion
NCT01335165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which ALXN1102 is the first listed.
NCT01335165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335165 about?
NCT01335165 is a clinical study titled "Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)". The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.
What is the current status of trial NCT01335165?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01335165?
The interventions under investigation include: ALXN1102 (DRUG), ALXN1103 (DRUG).
Who is sponsoring clinical trial NCT01335165?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01335165's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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