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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012323
Other study ID # NGAM01
Secondary ID
Status Completed
Phase Phase 3
First received November 11, 2009
Last updated August 24, 2012
Start date November 2009
Est. completion date August 2012

Study information

Verified date August 2012
Source Octapharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of NewGam in preventing serious bacterial infections, and on quality of life. The safety and pharmacokinetic profile of NewGam will also be evaluated.


Description:

NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for intravenous administration. It is supplied as a liquid formulation ready to use. IVIG has proved to be useful in a variety of clinical conditions other than for replacement of immunoglobulins, in which IVIG exhibits an immunomodulatory effect. Children and adults with PID have an increased risk of getting recurrent bacterial and viral infections that typically attack the respiratory tract (sinusitis, bronchitis, pneumonia) but can also affect the gastrointestinal tract (gastroenteritis). They can be severe and can lead to substantial morbidity. Responses to antibacterial therapy are often poor. At present, most primary immune deficiencies are not curable, but IVIGs have been shown to decrease the total number of severe infections and the duration of hospitalization.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 75 Years
Eligibility Inclusion Criteria:

- Age of = 2 years and = 75 years.

- Confirmed diagnosis of common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA).

- Previously treated with a commercial immune globulin intravenous (human) every 21-28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight.

Exclusion Criteria:

- Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.

- Exposure to blood or any blood product or derivative, other than commercially available IVIG, within the past 3 months prior to enrollment.

- Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product.

- Requirement of any routine pre-medication for IVIG infusion.

- Severe liver function impairment (alanine aminotransferase [ALAT] 3x > upper limit of normal).

- Presence of renal function impairment (creatinine > 120 µmol/L), or predisposition for acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs). History of autoimmune hemolytic anemia.

- History of diabetes mellitus.

- Congestive heart failure New York Heart Association (NYHA) class III or IV.

- Non-controlled arterial hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg).

- History of deep vein thrombosis or thrombotic complications of IVIG therapy.

- A positive result at screening on any of the following viral markers: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV).

- • Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, = 0.15 mg of prednisone or equivalent/kg/day), immunosuppressive or immunomodulatory drugs.

- Planned vaccination during the study period.

- Treatment with any investigational agent within 3 months prior to enrollment.

- Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrollment.

- Pregnant or nursing women.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
NewGam
Intravenous Q 3 weeks, up to .08 Ml/kg
NewGam
Q 4 weeks, Intravenous, up to .08 ml/kg

Locations

Country Name City State
United States Dr. Alan Knutsen St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Octapharma Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the efficacy of NewGam in preventing serious bacterial infections compared to historical control data. Every study visit (every 3 (Q 3) or every 4 (Q 4) weeks) No
Secondary To evaluate the safety of NewGam. Every study visit (Q 3 or Q 4 weeks) Yes
Secondary To determine the pharmacokinetic (PK) profile of NewGam. After week 24 for Q 3 week patients and after week 32 for Q 4 weeks patients No
Secondary To assess the effect of NewGam on quality of life (QoL) measures. 5 times during the 52 week trial No
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