CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
X4P-001drug
Likely dose
Mavorixafor 25 mg or 100 mg capsulesAI-extracted
Key inclusion· 4
  • Age ≥18 years
  • Genotype-confirmed CXCR4 mutation consistent with WHIM syndrome
  • Confirmed ANC ≤400/µL or ALC ≤650/µL or both
  • Willing and able to comply with protocol
Key exclusion· 5
  • Known hypersensitivity to mavorixafor or its inactive ingredients
  • Pregnant or nursing
  • Known HIV infection or AIDS
  • Hepatitis C antibody positive unless documented undetectable viral load on 2 independent samples

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03005327
NCT03005327Phase 2Completed

A Phase 2, Open-Label, Multi-Center Trial of Mavorixafor in Patients With WHIM Syndrome

X4 Pharmaceuticals·interventional·Posted Dec 29, 2016·Updated Oct 30, 2024

In Brief

A Phase 2 clinical trial evaluating X4P-001 for WHIM Syndrome. Completed, enrolled 8 participants across 2 sites in 2 countries.

Detailed Summary

This is a Phase 2 study with an initial 24-week Treatment Period and an Extension Phase. The primary objectives of this Phase 2 study are to determine the safety, tolerability, and dose selection of mavorixafor in participants with WHIM syndrome. Participants may continue treatment in an Extension Phase, if regionally applicable, until mavorixafor becomes available via an alternative mechanism (for example, drug is commercially available, an expanded access program, etc.) or until the study is terminated by the Sponsor for any reason.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWHIM Syndrome
CountriesAustralia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 29, 2016
Enrollment StartDec 1, 2016
Primary CompletionJun 16, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.5 years ago

Interventions

X4P-001drug

Mavorixafor will be provided as either 25 mg or 100 mg capsules.