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Anemia of Chronic DiseasePhase 2NCT01691040

Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

A Phase 2 study testing NOX-H94 in people with Anemia of Chronic Disease, run by TME Pharma AG at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia of Chronic Disease
What is being tested?
NOX-H94
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
11 sitesin 3 countries
Study dates
Sep 2012to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Previous participation in this study or treatment with an investigational agent <21 days prior to treatment start
  • Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
  • Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC) transfusions <21 days prior to treatment start
  • Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (e.g. lenalidomide, interferon)

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Romania5 sites

  • Spitalul Judetean

    Brasov, 500326

  • Institutul Oncologic

    Cluj-Napoca, 400124

  • Spitalul Municipal

    Craiova, 208028

  • Spitalul Judetean

    Târgu Mureş, 540136

  • Oncomed

    Timișoara, 300239

Other trials in Romania

Austria3 sites

  • University Hospital

    Graz, 8036

  • AKH Vienna

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Bulgaria3 sites

  • University Hospital

    Plovdiv, 4000

  • Tokuda Hospital

    Sofia, 1407

  • University Hospital

    Varna, 9010

Other trials in Bulgaria

About this study

Official title: Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

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.

Being tested
NOX-H94, Placebo solution
Keywords
Hepcidin, Iron, Anemia of Chronic Disease, Anemia, Cancer, Interleukin-6, Iron restriction, Lymphoma, CLL, Multiple Myeloma, Hodgkin, anti-hepcidin
Medical subject headings
Anemia, Neoplasms, Lymphoma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOX-H94Drug

    Also called lexaptepid pegol

    intravenous injection

  • Placebo solutionDrug

    Also called Glucose 5%

    intravenous injection

Study groups in NCT01691040
Study groupRoleWhat they receive
Open-label pilot groupExperimentalTwice weekly administration of NOX-H94
Receives: Drug: NOX-H94; Drug: Placebo solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: treatment start to 1 week after treatment end

Secondary outcomes (11)

  1. Response

    Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint

    Measured: Treatment start to 8 weeks after end of treatment

  2. Failure

    Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint

    Measured: Treatment start to 1 week after end of treatment

  3. Safety and tolerability

    Adverse events, Safety signals derived from laboratory diagnostics, vital signs.

    Measured: Treatment start to 8 weeks after end of treatment

  4. Pharmacokinetics

    NOX-H94 plasma concentrations

    Measured: Treatment start to 8 weeks after end of treatment

  5. Reticulocytes

    Absolute values and change from baseline

    Measured: Treatment start until 8 weeks after end of treatment

  6. Red blood cells

    Absolute values and change from baseline

    Measured: Treatment start until 8 weeks after end of treatment

  7. Transferrin

    Absolute concentrations and change from baseline

    Measured: Treatment start to 8 weeks after end of treatment

  8. Serum iron

    Absolute concentrations and change from baseline

    Measured: Treatment start to 8 weeks after end of treatment

  9. Ferritin

    Absolute concentrations and change from baseline

    Measured: Treatment start to 8 weeks after end of treatment

  10. Transferrin saturation

    Absolute concentrations and change from baseline

    Measured: Treatment start to 8 weeks after end of treatment

  11. Hemoglobin

    Absolute concentrations and change from baseline

    Measured: Treatment start to 8 weeks after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691040
Sponsor's protocol ID
SNOXH94C201
Other IDs
2012-001525-27
Status last verified
Jun 2014
First submitted
4 Sep 2012
Last updated
26 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30957581

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOX-H94 in people with Anemia of Chronic Disease, run by TME Pharma AG at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Romania, Austria, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of anemia (time frame: treatment start to 1 week after treatment end). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01691040, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.

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