NCT01691040

Brief Summary

This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the appropriate dose and dose schedule of subsequent efficacy studies. Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron concentrations in the blood and subsequently impair formation of red blood cells. Treatment with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating hepcidin.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

September 4, 2012

Last Update Submit

June 25, 2014

Conditions

Anemia of Chronic Disease

Keywords

HepcidinIronAnemia of Chronic DiseaseAnemiaCancerInterleukin-6Iron restrictionLymphomaCLLMultiple MyelomaHodgkinanti-hepcidin

Outcome Measures

Primary Outcomes (1)

  • Response rate of anemia

    • Hb increase ≥1 g/dL OR reticulocyte index normalization (≥1%) at any time point until 1 week after the end of treatment AND absence of all of the following treatment failure criteria until 1 week after the end of treatment: * Erythrocyte transfusion, ESA or IV iron, * Hb drop by ≥1 g/dL * Treatment interruption due to adverse events (AEs)

    treatment start to 1 week after treatment end

Secondary Outcomes (11)

  • Response

    Treatment start to 8 weeks after end of treatment

  • Failure

    Treatment start to 1 week after end of treatment

  • Safety and tolerability

    Treatment start to 8 weeks after end of treatment

  • Pharmacokinetics

    Treatment start to 8 weeks after end of treatment

  • Reticulocytes

    Treatment start until 8 weeks after end of treatment

  • +6 more secondary outcomes

Other Outcomes (2)

  • Exploratory analyses

    Treatment start to 1 week after end of treatment

  • Exploratory analyses

    Treatment start to 1 week after end of treatment

Study Arms (1)

Open-label pilot group

EXPERIMENTAL

Twice weekly administration of NOX-H94

Drug: NOX-H94Drug: Placebo solution

Interventions

NOX-H94DRUG

intravenous injection

Also known as: lexaptepid pegol
Open-label pilot group
Placebo solutionDRUG

intravenous injection

Also known as: Glucose 5%
Open-label pilot group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Female or male aged \>18 years
  • Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage: Hemoglobin (Hb) 7.0 g/dL to 10 g/dL, Transferrin saturation (TSAT) \<50%, Serum iron \<50 µg/dL (SI: \<9.0 µmol/L), AND Ferritin \>30 ng/mL (SI: \>30 µg/L)
  • Previous treatment with systemic anti-cancer therapy / regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Estimated life expectancy ≥12 weeks
  • Men must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment.

You may not qualify if:

  • Inability to personally provide written informed consent or to understand and collaborate throughout the study
  • History of pure red cell aplasia, thalassemia major or sickle cell disease History of anemia unrelated to cancer \<10 g/dL within 6 months prior to screening
  • Uncorrected iron deficiency
  • Regular need for blood transfusions at intervals \<6 weeks
  • Acute or myeloid leukemia
  • Known or suspected chronic bleeding
  • Tumor with gastro-intestinal involvement without negative test for fecal occult blood
  • Suspected or known history of hemochromatosis
  • Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
  • Impaired liver function with bilirubin ≥2.0 mg/dL (26 μmol/L), AST or ALT ≥2 times upper limit
  • History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
  • Severe renal impairment: estimated glomerular filtration rate (eGFR) \<30 mL/min (Cockcroft-Gault)
  • Known central nervous system malignancy or metastasis
  • Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure \[BP\] \>150 mmHg or diastolic BP \>100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
  • Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Hospital

Graz, 8036, Austria

Location

AKH Vienna

Vienna, 1090, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

University Hospital

Plovdiv, 4000, Bulgaria

Location

Tokuda Hospital

Sofia, 1407, Bulgaria

Location

University Hospital

Varna, 9010, Bulgaria

Location

Spitalul Judetean

Brasov, 500326, Romania

Location

Institutul Oncologic

Cluj-Napoca, 400124, Romania

Location

Spitalul Municipal

Craiova, 208028, Romania

Location

Spitalul Judetean

Târgu Mureş, 540136, Romania

Location

Oncomed

Timișoara, 300239, Romania

Location

Related Publications (1)

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

    PMID: 30957581DERIVED

MeSH Terms

Conditions

AnemiaNeoplasmsLymphomaMultiple Myeloma

Interventions

NOX-H94

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Kai Riecke, MD

    TME Pharma AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 24, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

RO(5)AU(3)BU(3)