deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00295061

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults (ChAMP)

Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.

Sponsor: Grifols Therapeutics LLC

Conditions Alpha 1-Antitrypsin Deficiency
Interventions Alpha-1 MP alpha-1 proteinase inhibitor (human)
Updated 9 times since 2017 Last updated: Aug 28, 2014 Started: May 31, 2006 Primary completion: Feb 28, 2007 Completion: Feb 28, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00295061, this PHASE3 trial focuses on Alpha 1-Antitrypsin Deficiency and remains completed. Sponsored by Grifols Therapeutics LLC, it has been updated 9 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency. This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency.

This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

▶ Show 4 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Apr 2018 — Jun 2018 [monthly]

    Completed PHASE3

  3. Feb 2017 — Apr 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

May 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
Data source: Grifols Therapeutics LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations