A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India

Inclusion Criteria:

• Male or female Elaprase naive participants (and who are not part of any otherprogram at the time of study enrollment and during the study period) of any age withconfirmed diagnosis of Hunter syndrome based on the following documented biochemicaland genetic criteria:

• Documented deficiency in iduronate 2-sulfatase (IDS [12S]) enzyme activity ofless than or equal to 10 percent (%) of the lower limit of the normal range asmeasured in plasma, fibroblasts, or leukocytes (based on normal range ofmeasuring laboratory).

• A normal enzyme activity level of one other sulfatase as measured in plasma,fibroblasts, or leukocytes (based on normal range of measuring laboratory).

• The participant has a documented mutation in the IDS gene.

• In the opinion of the investigator, the participant or the participant'sparents/guardians are capable of understanding and complying with protocolrequirements.

• The participant or, when applicable, the participant's parents/guardians/legalauthorized representative (LAR) signs and dates a written, informed consent form andany required privacy authorization prior to the initiation of any study procedures.If the participant participating in this study is greater than or equal to (>=) 7years and less than (<) 18 years of age signs and dates an assent form.

• A male participant who is nonsterilized and sexually active with a female partner ofchildbearing potential agrees to use barrier method of contraception (example,condom with or without spermicide) from signing of informed consent throughout theduration of the study. The female partner of a male participant should also beadvised to use a highly effective/effective method of contraception.

• A female participant of childbearing potential who is sexually active with anonsterilized male partner agrees to use a highly effective method of contraceptionfrom signing of informed consent throughout the duration of the study.

Exclusion criteria:

• Participant has received hematopoietic stem cell transplant (HSCT) or a bone marrowtransplant at any time.

• Participant is unable to comply with the protocol, example, uncooperative withprotocol schedule, refusal to agree to all of the study procedures, inability toreturn for safety evaluations, or is otherwise unlikely to complete the study, asdetermined by the investigator.

• Participant is suffering from any comorbid conditions (including hepatic impairment,acute or chronic) or having any other clinical observation or history during thescreening examination, which would interfere with the objectives of the study as perinvestigators judgement.

• The participant has a chronic kidney disease with estimated Glomerular Filtrationrate less than 15 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)and/or is on dialysis.

• The participant is an immediate family member, study site employee, or is in adependent relationship with a study site employee who is involved in conduct of thisstudy (example, spouse, parent, child, sibling) or may consent under duress.

• The participant has a history of hypersensitivity or allergies to related compoundsincluding any associated excipients.

• If female, the participant is pregnant or lactating or intending to become pregnantbefore participating in this study, during the study; or intending to donate ovaduring such time period.

• If male, the participant intends to donate sperm during the course of this study.

• The participant has participated in another clinical study or received anyinvestigational compound or non-investigational idursulfase beta within the past 30days before informed consent.