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Trial record 19 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults

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ClinicalTrials.gov Identifier: NCT03327727
Recruitment Status : Terminated (Business decision)
First Posted : October 31, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Vical

Brief Summary:
The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Invasive Pulmonary Aspergillosis Drug: Investigational Agent: VL-2397 Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B Phase 2

Detailed Description:
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Sponsor, safety monitoring board, and data review committee are masked.
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : January 14, 2019


Arm Intervention/treatment
Experimental: VL-2397
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
Drug: Investigational Agent: VL-2397
VL-2397

Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B

Active Comparator: Standard (First-Line) Treatment
Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Voriconazole, Isavuconazole, or Liposomal amphotericin B




Primary Outcome Measures :
  1. All-cause mortality (ACM) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. ACM [ Time Frame: 6 weeks ]
  2. Number of participants with adverse events [ Time Frame: 6 weeks ]
    Number of participants with adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA

Exclusion Criteria:

  • Pregnant or breastfeeding
  • IA involving sites other than lungs and sinuses
  • Graft failure, acute or extensive chronic GvHD
  • Uncontrolled diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327727


  Show 28 Study Locations
Sponsors and Collaborators
Vical
Investigators
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Study Director: Mammen P Mammen, MD, FIDSA Vical

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Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT03327727     History of Changes
Other Study ID Numbers: VL2397-201
2017-003435-11 ( EudraCT Number )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vical:
IA

Additional relevant MeSH terms:
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Anti-Infective Agents
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections
Voriconazole
Amphotericin B
Liposomal amphotericin B
Isavuconazole
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents