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Trial · Interventional

CompletedPhase 3Results postedRegistry data

An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

NCTNCT00226655 (opens ClinicalTrials.gov in a new tab)Other idNTI 0501
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
112 participants (actual)
Sponsor
Celtic Pharma Development Services · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Jul 2005
Primary completion
Mar 2009
Completion
Apr 2009
First posted
27 Sept 2005 (estimated)
Last update posted
31 Aug 2012 (estimated)
Conditions
Brain Edema · Brain Tumor

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007200820092010
  1. Ph 3

    An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

    NCT00226655

    Jul 2005 to Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Interventions

  • hCRF [XERECEPT (corticorelin acetate injection)]Drug

Arms1

  • Experimental

    I

    All patients will receive hCRF (XERECEPT) 2mg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Long Term Safety and Tolerability of hCRF

    Time frame · Prospective

    Registry description

    Number of patients reporting adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Prospective

Long Term Safety and Tolerability of hCRF

GroupValue (Participants)Spread
hCRF1114.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
hCRFAll patients will receive hCRF (XERECEPT) 2mg/day–72 / 112111 / 112

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies. * Have a Karnofsky Performance of \> 50 at Baseline * Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver. * Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent. * For women of childbearing potential: a negative serum pregnancy test at Baseline Exclusion Criteria: * Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies. * Systemic steroid use for any indication other than peritumoral brain edema. * Use or intended use of dexamethasone as an anti-emetic during study. * Clinical signs and symptoms of cerebral herniation. * Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation. * Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation. * Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed) * Central nervous system (CNS) infection. * Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.

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