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NCT01791686 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease
A Phase 1 study, sponsored by Celldex Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01791686: Clinical Trial Phase 1 study, sponsored by Celldex Therapeutics.
NCT01791686 is a Phase 1 study that was terminated before completion, run by Celldex Therapeutics. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791686, a Phase 1 study, was terminated before completion, sponsored by Celldex Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in pediatric and adult patients with DDD. After screening, eligible patients will be entered into the Induction Period. The Induction Period is up to 4 weeks. Following normalization of complement activity, patients will enter into the Maintenance Period.The total treatment duration is up to 26 weeks.
Primary Outcome
* Incidence and severity of adverse events (AE) will be assessed at every visit. AEs and serious adverse events (SAEs) will be assessed from the first dose of study drug through 33 days after the last dose * To evaluate the safety of repeated dosing in patients with DDD. Safety will be assessed based on changes in clinical laboratory tests, physical exams, vital signs, ophthalmic exams and ECGs \[for patients ≥ 35 years of age\].
Interventions
- DRUG CDX-1135
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
Why NCT01791686 stopped before completion
NCT01791686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which CDX-1135 is the first listed.
NCT01791686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01791686 about?
NCT01791686 is a clinical study titled "Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit Disease". This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in pediatric and adult patients with DDD. After screening, eligible patients will be entered into the Induction Period. ...
What is the current status of trial NCT01791686?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2013-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01791686?
The interventions under investigation include: CDX-1135 (DRUG).
Who is sponsoring clinical trial NCT01791686?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01791686's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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